Trial Outcomes & Findings for Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma (NCT NCT01465347)
NCT ID: NCT01465347
Last Updated: 2017-07-14
Results Overview
Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
During phase 1
Results posted on
2017-07-14
Participant Flow
Treatment naive patients with a histologically confirmed diagnosis of GBM who were scheduled to receive standard-of-care radiation and temozolomide treatment per Stupp et al (2005) were enrolled in the study at 18 academic clinical sites in the U.S.
Open-label, historical control (Stupp et al; N Engl J Med 2005; 352: 987-996, March 10, 2005, DOI: 10.1056/NEJMoa043330); patients received standard-of-care radiation/temozolomide treatment plus Trans Sodium Crocetinate (TSC); three (3) patients completed 9 doses (phase 1) as a safety run-in followed by 56 patients who received 18 doses (phase 2).
Participant milestones
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
56
|
|
Overall Study
COMPLETED
|
2
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Admitted to hospice
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
Baseline characteristics by cohort
| Measure |
TSC 0.25 mg/kg for 9 or 18 Doses
n=56 Participants
Trans Sodium Crocetinate (TSC): TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 10.79 • n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=99 Participants
|
|
Count of participants
|
56 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During phase 1Population: Dose limiting toxicities were only assessed for Phase 1 participants
Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)
Outcome measures
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
n=3 Participants
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Dose Limiting Toxicities (DLTs)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24 monthsPopulation: All participants who received any amount of TSC and at least 1 session of RT (modified ITT)
Participants in phase 2 (18 dose group, 6 weeks treatment with TSC) were monitored for up to 3 years (last follow-up - February 16, 2016). Overall Survival (OS) was defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death. The OS analyses were performed using the Kaplan-Meier estimate method. The OS rates at 6, 12, 18 and 24 months were estimated. Median OS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. The length of OS (in months) was calculated as follows: date of death or censored - date of surgery or definitive biopsy / 30.4375.
Outcome measures
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
n=56 Participants
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Overall Survival
6 month OS
|
89.3 participants
Interval 81.18 to 97.39
|
—
|
|
Overall Survival
12 month OS
|
71.2 participants
Interval 59.22 to 83.09
|
—
|
|
Overall Survival
18 month OS
|
43.8 participants
Interval 30.67 to 56.9
|
—
|
|
Overall Survival
24 month OS
|
36.3 participants
Interval 23.55 to 49.08
|
—
|
SECONDARY outcome
Timeframe: 6,12,18, 24 monthsPopulation: The analysis of PFS was performed in phase 2 only and included the modified ITT population which included 54 of the 56 subjects (98.2%) at the 2-year time point.
The PFS analyses were performed using the Kaplan-Meier estimate method. The PFS rates at 6, 12, 18 and 24 months were estimated. Median PFS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. Time to disease progression (in months) was calculated as follows: date of event\* or censoring - date of surgery or definitive biopsy / 30.4375; \*event = first tumor progression or death.
Outcome measures
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
n=56 Participants
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Progression-Free Survival (PFS)
6 months
|
30.9 percentage of participants
Interval 18.7 to 43.12
|
—
|
|
Progression-Free Survival (PFS)
12 months
|
9.9 percentage of participants
Interval 1.8 to 18.03
|
—
|
|
Progression-Free Survival (PFS)
18 months
|
4.0 percentage of participants
Interval 0.0 to 9.32
|
—
|
|
Progression-Free Survival (PFS)
24 months
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 110Population: Of the 56 modified ITT population (subjects in the TSC 18 dose group) tumor size data exist for 37 subjects. Four (4) tumor-bearing subjects at baseline MRI did not have any post-baseline MRIs. Fourteen (14) subjects had a complete resection before baseline.
The sum of the product of the diameters of the tumor (using recorded tumor diameter measurements made from brain MRI images) was used to express tumor size. Results were summarized for actual and percentage change from baseline. Individual subjects results were listed, including tumor volume and tumor response from independent reviewers. Investigator data were listed but not used in the analysis. Percent response (according to independent reviewer assessments) by percentage tumor reduction from tumor resection or definitive biopsy to the last MRI were summarized.
Outcome measures
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
n=3 Participants
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
n=37 Participants
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
100% tumor reduction
|
2 Participants
|
11 Participants
|
|
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
tumor not reduced
|
1 Participants
|
10 Participants
|
|
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
0 to 39% tumor reduction
|
0 Participants
|
6 Participants
|
|
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
40 to 63% tumor reduction
|
0 Participants
|
2 Participants
|
|
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
64 to 93% tumor reduction
|
0 Participants
|
6 Participants
|
|
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
94 to 99% tumor reduction
|
0 Participants
|
2 Participants
|
Adverse Events
TSC 0.25 mg/kg - 9 Dose Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
TSC 0.25 mg/kg - 18 Dose Group
Serious events: 10 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
n=3 participants at risk
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
n=56 participants at risk
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
Infections and infestations
Neutropenia sepsis
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
0.00%
0/56 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Infections and infestations
Tooth abscess
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
0.00%
0/56 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
3.6%
2/56 • Number of events 2 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
3.6%
2/56 • Number of events 2 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
3.6%
2/56 • Number of events 2 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Brain edema
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
1.8%
1/56 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
Other adverse events
| Measure |
TSC 0.25 mg/kg - 9 Dose Group
n=3 participants at risk
Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
|
TSC 0.25 mg/kg - 18 Dose Group
n=56 participants at risk
Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
42.9%
24/56 • Number of events 25 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
3/3 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
32.1%
18/56 • Number of events 20 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
28.6%
16/56 • Number of events 17 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
28.6%
16/56 • Number of events 16 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
21.4%
12/56 • Number of events 13 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
17.9%
10/56 • Number of events 13 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
16.1%
9/56 • Number of events 9 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
General disorders
Edema peripheral
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
12.5%
7/56 • Number of events 7 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
12.5%
7/56 • Number of events 7 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
10.7%
6/56 • Number of events 11 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
8.9%
5/56 • Number of events 6 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
8.9%
5/56 • Number of events 5 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
8.9%
5/56 • Number of events 5 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
8.9%
5/56 • Number of events 5 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 4 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
7.1%
4/56 • Number of events 4 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
7.1%
4/56 • Number of events 4 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
7.1%
4/56 • Number of events 4 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
General disorders
Injection site bruising
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 4 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 4 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
General disorders
Face edema
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
General disorders
Irritability
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
5.4%
3/56 • Number of events 3 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
3.6%
2/56 • Number of events 2 • The first subject was enrolled February 27, 2012 and the last subject completed treatment on April 28, 2015. The last follow-up of the last subject was February 16, 2016. Adverse events were collected from the first dose of TSC to 30 days following the last dose (week 10 study visit). Subjects who experienced multiple events with the same preferred term were counted once for that preferred term.
This was an open-label, sequential cohort, dose escalation study designed to evaluate the safety and efficacy of TSC administered concomitantly with standard-of-care RT and temozolomide in adults with GBM. The study included two phases. Phase 1 was a safety run-in wherein 3 subjects received 9 doses at 3 doses per week for 3 weeks. Phase 2 engaged 56 patients who received 18 doses at 3 doses per week for 6 weeks. The dose of TSC was consistently 0.25mg/kg.
|
Additional Information
Chief Executive Officer
Diffusion Pharmaceuticals Inc
Phone: (434) 220-0718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place