Trial Outcomes & Findings for A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC (NCT NCT02346370)
NCT ID: NCT02346370
Last Updated: 2019-02-08
Results Overview
DLTs were defined as adverse events (AEs) that occurred during Cycle 1 in the Dose Escalation portion of the study, and deemed by the Investigator as related to study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Cycle 1 (Day 1 through Day 21) (1 Cycle = 21 days)
Results posted on
2019-02-08
Participant Flow
A total of 16 participants were enrolled, of whom 1 participant was not treated due to disease progression prior to treatment and 15 participants received study treatment.
Participant milestones
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
0
|
|
Overall Study
Withdrawal of consent
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
3
|
1
|
|
Overall Study
Sponsor discontinued study
|
5
|
0
|
2
|
|
Overall Study
Radiologic progression
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
n=7 Participants
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
n=4 Participants
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
n=4 Participants
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 8.90 • n=99 Participants
|
57.8 years
STANDARD_DEVIATION 10.53 • n=107 Participants
|
65.5 years
STANDARD_DEVIATION 8.10 • n=206 Participants
|
62.6 years
STANDARD_DEVIATION 9.03 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 1 through Day 21) (1 Cycle = 21 days)Population: The DLT-Evaluable population included all participants who received a full dose of study treatment and completed the initial 21 days of the study after the first dose or who experienced a DLT within the initial 21 days after the first dose and discontinued from the study (if they received a full dose of study drug).
DLTs were defined as adverse events (AEs) that occurred during Cycle 1 in the Dose Escalation portion of the study, and deemed by the Investigator as related to study treatment.
Outcome measures
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
n=7 Participants
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
n=4 Participants
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
n=4 Participants
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
|---|---|---|---|
|
Number of Dose Limiting Toxicities (DLTs)
Gastroenteritis Escherichia coli
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
|
Number of Dose Limiting Toxicities (DLTs)
Neutropenia
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
|
Number of Dose Limiting Toxicities (DLTs)
Sepsis
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
|
Number of Dose Limiting Toxicities (DLTs)
Deep vein thrombosis
|
0 DLTs
|
1 DLTs
|
1 DLTs
|
PRIMARY outcome
Timeframe: From date of first dose until 30 days after the last dose of study treatment, up to approximately 1 year 10 monthsPopulation: Safety population
Throughout the Treatment Period, the assessment of safety was based on AEs, including deaths, non-serious AEs, and serious adverse events, AEs leading to discontinuation of study treatment, and results of vital sign measurements and clinical laboratory assessments (including hematology, clinical chemistry, coagulation parameters, and urinalysis). Additionally, thromboembolic (TE) events were deemed by the Sponsor as AEs of special interest. AEs and laboratory values were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Outcome measures
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
n=7 Participants
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
n=4 Participants
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
n=4 Participants
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
|---|---|---|---|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
AEs greater than or equal to grade 3
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
PEGPH20-related AEs
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
Docetaxel-related AEs
|
7 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
AEs with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
SAEs
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
Treatment-related SAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel
AEs leading to discontinuation of study drug
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 of Dose Escalation portion (Cycle 1 = 21 days)Population: The MTD and RP2D were not established due to early study discontinuation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, Cmax was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated electrochemiluminescence (ECL) immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with tandem mass spectrometry assay (LS-MS/MS). The following blood draw schedule was used, PEGPH20: Cycle 1 Day 1 (C1D1) (predose, 15 minutes (min), 1, 2 to 4, and 24 hours (hr) postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, Cmin was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, Tmax was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, t1/2 was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, the AUC was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, Vd was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2Population: Due to early discontinuation of the study, CL was not assessed.
Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment start until disease progression or up to data cutoff date (30 Nov 2016), for up to approximately 1 year 9 monthsPopulation: Due to early discontinuation of the study, ORR was not assessed.
ORR = complete response + partial response (CR + PR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment start until disease progression or up to data cutoff date (30 Nov 2016), for up to approximately 1 year 9 monthsPopulation: Due to early discontinuation of the study, DCR was not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first CR or PR until the date of first documentation of disease progression or date of death, assessed up to data cutoff date (30 Nov 2016)Population: Due to early discontinuation of the study, DoR was not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment start until date of first documentation of progressive disease or death from any cause, assessed up to 1 year 9 monthsPopulation: Due to early discontinuation of the study, PFS was not assessed.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
n=7 participants at risk
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
n=4 participants at risk
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
n=4 participants at risk
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel
n=7 participants at risk
1.6 micrograms/kilograms (ug/kg) PEGylated recombinant human hyaluronidase PH20 (PEGPH20) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel
n=4 participants at risk
3.0 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel
n=4 participants at risk
2.2 ug/kg PEGPH20 was administered on Day 1 of each 21-day cycle (every 3 weeks) as an IV-infusion over 10 minutes, approximately 1 mL/min (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 mg/m\^2) was administered as an IV-infusion on Day 2 of each 21-day cycle.
|
|---|---|---|---|
|
General disorders
Fatigue
|
85.7%
6/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
75.0%
3/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
100.0%
4/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
42.9%
3/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
57.1%
4/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
General disorders
Local swelling
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
57.1%
4/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
75.0%
3/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
57.1%
4/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
75.0%
3/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
42.9%
3/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
75.0%
3/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuropathy Peripheral
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
28.6%
2/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Candida infection
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
42.9%
3/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Cushingoid
|
14.3%
1/7 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. Adverse event severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The Safety Population was evaluated and included all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER