Trial Outcomes & Findings for 1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy (NCT NCT00493636)
NCT ID: NCT00493636
Last Updated: 2014-05-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.
Results posted on
2014-05-20
Participant Flow
The period of study was 28 Jun 2007 (first subject randomized) to 29 Feb 2012 (overall survival data cutoff date). There were 40 centers in the United States that participated in this trial.
181 patients were assessed for eligiblity. Of these, 21 patients were excluded from the trial due to not meeting the eligibility criteria, leaving 160 patients who were randomized.
Participant milestones
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
79
|
|
Overall Study
COMPLETED
|
79
|
77
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Disease progression/recurrence/relapse
|
0
|
1
|
|
Overall Study
Mis-randomization
|
1
|
1
|
Baseline Characteristics
1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy
Baseline characteristics by cohort
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=81 Participants
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=79 Participants
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
54.2 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=99 Participants
|
79 participants
n=107 Participants
|
160 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.Outcome measures
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=81 Participants
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=79 Participants
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Progression Free Survival
|
103 Days
Interval 83.0 to 128.0
|
81 Days
Interval 48.0 to 95.0
|
SECONDARY outcome
Timeframe: From the date of randomization to date of death due to any cause, assessed up to 56 months.Outcome measures
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=81 Participants
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=79 Participants
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Overall Survival
|
407 Days
Interval 308.0 to 492.0
|
348 Days
Interval 297.0 to 457.0
|
SECONDARY outcome
Timeframe: Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.Outcome measures
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=81 Participants
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=79 Participants
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Time to Progression
|
111 Days
Interval 85.0 to 128.0
|
82 Days
Interval 48.0 to 95.0
|
SECONDARY outcome
Timeframe: The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Outcome measures
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=81 Participants
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=79 Participants
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Overall Response Rate
|
19.8 percentage of participants
|
12.7 percentage of participants
|
SECONDARY outcome
Timeframe: Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Outcome measures
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=81 Participants
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=79 Participants
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Duration of Overall Response
|
94 Days
Interval 68.0 to 134.0
|
147 Days
Interval 86.0 to 372.0
|
Adverse Events
A (Sorafenib + Gemcitabine or Capecitabine)
Serious events: 32 serious events
Other events: 78 other events
Deaths: 0 deaths
B (Placebo + Gemcitabine or Capecitabine)
Serious events: 28 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=79 participants at risk
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=77 participants at risk
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.8%
3/79
|
2.6%
2/77
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/79
|
3.9%
3/77
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/79
|
2.6%
2/77
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
2/79
|
1.3%
1/77
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/79
|
2.6%
2/77
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
2/79
|
0.00%
0/77
|
|
Infections and infestations
Pneumonia
|
2.5%
2/79
|
6.5%
5/77
|
|
Infections and infestations
Cellulitis
|
0.00%
0/79
|
2.6%
2/77
|
|
General disorders
Disease progression
|
2.5%
2/79
|
2.6%
2/77
|
|
General disorders
Pyrexia
|
1.3%
1/79
|
3.9%
3/77
|
|
General disorders
Fatigue
|
3.8%
3/79
|
0.00%
0/77
|
|
General disorders
Mucosal inflammation
|
2.5%
2/79
|
0.00%
0/77
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
2/79
|
2.6%
2/77
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
3/79
|
1.3%
1/77
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/79
|
2.6%
2/77
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
2/79
|
0.00%
0/77
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/79
|
2.6%
2/77
|
|
Vascular disorders
Deep vein thrombosis
|
5.1%
4/79
|
1.3%
1/77
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
2/79
|
0.00%
0/77
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
2/79
|
0.00%
0/77
|
Other adverse events
| Measure |
A (Sorafenib + Gemcitabine or Capecitabine)
n=79 participants at risk
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
B (Placebo + Gemcitabine or Capecitabine)
n=77 participants at risk
Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
44.3%
35/79
|
49.4%
38/77
|
|
Gastrointestinal disorders
Diarrhea
|
36.7%
29/79
|
22.1%
17/77
|
|
Gastrointestinal disorders
Constipation
|
22.8%
18/79
|
27.3%
21/77
|
|
Gastrointestinal disorders
Vomiting
|
26.6%
21/79
|
23.4%
18/77
|
|
Gastrointestinal disorders
Stomatitis
|
26.6%
21/79
|
6.5%
5/77
|
|
Gastrointestinal disorders
Abdominal pain
|
13.9%
11/79
|
13.0%
10/77
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
4/79
|
6.5%
5/77
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
4/79
|
5.2%
4/77
|
|
General disorders
Fatigue
|
62.0%
49/79
|
49.4%
38/77
|
|
General disorders
Pyrexia
|
19.0%
15/79
|
20.8%
16/77
|
|
General disorders
Pain
|
13.9%
11/79
|
10.4%
8/77
|
|
General disorders
Mucosal inflammation
|
13.9%
11/79
|
6.5%
5/77
|
|
General disorders
Edema peripheral
|
8.9%
7/79
|
6.5%
5/77
|
|
General disorders
Chest pain
|
7.6%
6/79
|
6.5%
5/77
|
|
General disorders
Chills
|
6.3%
5/79
|
5.2%
4/77
|
|
General disorders
Asthenia
|
2.5%
2/79
|
6.5%
5/77
|
|
General disorders
Influenza like illness
|
5.1%
4/79
|
1.3%
1/77
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
57.0%
45/79
|
18.2%
14/77
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
22/79
|
16.9%
13/77
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
6/79
|
6.5%
5/77
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.9%
7/79
|
3.9%
3/77
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.5%
17/79
|
24.7%
19/77
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.8%
18/79
|
20.8%
16/77
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.5%
13/79
|
11.7%
9/77
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.9%
7/79
|
6.5%
5/77
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.6%
6/79
|
3.9%
3/77
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.6%
6/79
|
2.6%
2/77
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
9/79
|
18.2%
14/77
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
9/79
|
18.2%
14/77
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.0%
15/79
|
9.1%
7/77
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
2/79
|
6.5%
5/77
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
4/79
|
3.9%
3/77
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.3%
5/79
|
1.3%
1/77
|
|
Nervous system disorders
Headache
|
24.1%
19/79
|
18.2%
14/77
|
|
Nervous system disorders
Dizziness
|
6.3%
5/79
|
13.0%
10/77
|
|
Nervous system disorders
Neuropathy
|
7.6%
6/79
|
2.6%
2/77
|
|
Nervous system disorders
Dysgeusia
|
6.3%
5/79
|
1.3%
1/77
|
|
Nervous system disorders
Neuropathy peripheral
|
5.1%
4/79
|
2.6%
2/77
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.3%
1/79
|
6.5%
5/77
|
|
Nervous system disorders
Paresthesia
|
1.3%
1/79
|
5.2%
4/77
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.1%
19/79
|
27.3%
21/77
|
|
Blood and lymphatic system disorders
Anemia
|
15.2%
12/79
|
7.8%
6/77
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.7%
10/79
|
10.4%
8/77
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.3%
5/79
|
6.5%
5/77
|
|
Investigations
Weight decreased
|
13.9%
11/79
|
3.9%
3/77
|
|
Investigations
Aspartate aminotransferase increased
|
5.1%
4/79
|
9.1%
7/77
|
|
Investigations
Alanine aminotransferase increased
|
6.3%
5/79
|
6.5%
5/77
|
|
Investigations
Neutrophil count decreased
|
6.3%
5/79
|
3.9%
3/77
|
|
Investigations
Hemoglobin abnormal
|
2.5%
2/79
|
5.2%
4/77
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
15/79
|
9.1%
7/77
|
|
Metabolism and nutrition disorders
Dehydration
|
8.9%
7/79
|
5.2%
4/77
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.3%
5/79
|
3.9%
3/77
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/79
|
5.2%
4/77
|
|
Infections and infestations
Pneumonia
|
2.5%
2/79
|
7.8%
6/77
|
|
Infections and infestations
Sinusitis
|
5.1%
4/79
|
2.6%
2/77
|
|
Vascular disorders
Hypertension
|
20.3%
16/79
|
9.1%
7/77
|
|
Vascular disorders
Hot flush
|
7.6%
6/79
|
3.9%
3/77
|
|
Vascular disorders
Deep vein thrombosis
|
6.3%
5/79
|
1.3%
1/77
|
|
Psychiatric disorders
Anxiety
|
3.8%
3/79
|
7.8%
6/77
|
|
Psychiatric disorders
Insomnia
|
3.8%
3/79
|
5.2%
4/77
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Onyx has the right to require the deletion of any "Confidential Information" in a publication. If Onyx believes that information contained in the publication is patentable and communicates that in writing, the submission/delivery of the publication may be delayed for up to 60 additional days to allow for the filing of a United States (and any other appropriate) patent application(s).
- Publication restrictions are in place
Restriction type: OTHER