Trial Outcomes & Findings for Dose-Intense Temozolomide in Recurrent Glioblastoma (NCT NCT00657267)
NCT ID: NCT00657267
Last Updated: 2014-03-14
Results Overview
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
6 months
Results posted on
2014-03-14
Participant Flow
Study activated at DFCI in May 2008 and was eventually activated at MGH, UPENN, Wake Forest University Baptist Medical Center, Dartmouth-Hitchcock Medical Center, and Tufts NEMC.
Participant milestones
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|
|
Overall Study
Progressive disease
|
45
|
|
Overall Study
Adverse Event
|
9
|
Baseline Characteristics
Dose-Intense Temozolomide in Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=58 Participants
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
|
Age, Continuous
|
57 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Karnofsky performance status (KPS) at registration
|
90 %
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patients evaluable for imaging analysis, as protocol-defined.
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=55 Participants
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
Complete Response
Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|---|
|
6 Month Progression Free Survival
|
11 percentage of evaluable participants
|
—
|
SECONDARY outcome
Timeframe: From patient registration until end of study, assessed up to 54 monthsPopulation: Entire study population
Outcome measures
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=58 Participants
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
Complete Response
Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|---|
|
Overall Survival
|
11.7 months
Interval 8.1 to 16.2
|
—
|
SECONDARY outcome
Timeframe: From patient registration until end of study, assessed up to 54 monthsPopulation: Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.
Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) \>/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response \</= max dose w/in the first 8 weeks of therapy.
Outcome measures
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=55 Participants
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
Complete Response
n=55 Participants
Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|---|
|
Radiographic Response
|
13 percentage of participants evaluated
|
0 percentage of participants evaluated
|
SECONDARY outcome
Timeframe: From patient registration until end of study, assessed up to 54 monthsPopulation: Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=55 Participants
Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
Complete Response
Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets)
|
|---|---|---|
|
Time to Progression.
|
56 days
Interval 56.0 to 84.0
|
—
|
Adverse Events
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
Serious events: 19 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=58 participants at risk
All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets
|
|---|---|
|
General disorders
Disease Progression NOS
|
3.4%
2/58 • Number of events 2 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.1%
7/58 • Number of events 18 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Seizure
|
10.3%
6/58 • Number of events 6 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neurology - Other
|
3.4%
2/58 • Number of events 2 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.4%
2/58 • Number of events 2 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Platelets
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Speech impairment
|
3.4%
2/58 • Number of events 2 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - left-sided
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus tachycardia
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Pain - headache
|
1.7%
1/58 • Number of events 2 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Number of events 4 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Number of events 4 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • Number of events 4 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Distension/bloating,
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (Hypokalemia)
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
General disorders
Pain - Chest NOS
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Enteritis
|
1.7%
1/58 • Number of events 2 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other
|
3.4%
2/58 • Number of events 3 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
General disorders
Fatigue
|
1.7%
1/58 • Number of events 1 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
Other adverse events
| Measure |
12 Cycles of Dose-Dense Temozolomide (Single Arm Study)
n=58 participants at risk
All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC \&/or gr 2 platelets
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
43.1%
25/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Leukocytes
|
58.6%
34/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
84.5%
49/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Neutrophils
|
29.3%
17/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Platelets
|
51.7%
30/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
INR
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
General disorders
Fatigue
|
70.7%
41/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
General disorders
Insomnia
|
17.2%
10/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Endocrine disorders
Cushingnoid appearance
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Anorexia
|
6.9%
4/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
32.8%
19/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
15.5%
9/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
4/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Incontinence- anal
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
31.0%
18/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
7/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Edema limb
|
22.4%
13/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
12.1%
7/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
ALT- SGPT
|
24.1%
14/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
AST- SGOT
|
22.4%
13/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
17.2%
10/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Bilirubin
|
13.8%
8/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Creatinine
|
6.9%
4/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
67.2%
39/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.7%
12/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.3%
6/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.7%
12/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.4%
13/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.8%
8/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.5%
9/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.8%
8/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Proteinuria
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
24.1%
14/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
12.1%
7/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
10.3%
6/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic right-side muscle weak
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Anxiety
|
10.3%
6/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Ataxia
|
6.9%
4/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Cognitive disturbance
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Confusion
|
25.9%
15/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Depressed level of consciousness
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Depression
|
15.5%
9/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Dizziness
|
15.5%
9/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Memory impairment
|
37.9%
22/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neuropathy CN II vision
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neuropathy CN VII face-motor / taste
|
10.3%
6/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neuropathy CN VIII hearing & balance
|
10.3%
6/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neuropathy-motor
|
37.9%
22/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neuropathy-sensory
|
24.1%
14/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Seizure
|
19.0%
11/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Speech impairment
|
29.3%
17/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Tremor
|
6.9%
4/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Eye disorders
Cataract
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Eye disorders
Vision-blurred
|
13.8%
8/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdomen- pain
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back- pain
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb- pain
|
6.9%
4/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Head/headache
|
41.4%
24/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Joint- pain
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
6/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.6%
5/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Incontinence urinary
|
17.2%
10/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.2%
3/58 • SAEs are reported from the signing of the consent form until the 30-Days-After-Last Dose-of Study Drug Visit. (Any SAEs occurring within the 30 days after last dose of study drug need to be followed until resolved.)
AEs collected via regular Investigator assessment and regular laboratory testing.
|
Additional Information
Patrick Y. Wen, MD
Dana-Farber Cancer Institute / Brigham & Women's Hospital
Phone: 617-632-2166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60