Trial Outcomes & Findings for A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B) (NCT NCT00434356)
NCT ID: NCT00434356
Last Updated: 2009-12-03
Results Overview
The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From randomization until disease progression/recurrence (by patient)
Results posted on
2009-12-03
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)
Baseline characteristics by cohort
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 18 Years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 40 Years
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age, Customized
Between 41 and 64 Years
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
>= 65 Years
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age Continuous
|
57.3 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
54 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression/recurrence (by patient)Population: Randomized patients with at least one scan available at baseline and post-baseline
The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=17 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=18 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Best Response
Unable to Evaluate
|
0 participants
|
1 participants
|
|
Best Response
Missing
|
0 participants
|
0 participants
|
|
Best Response
Complete Response
|
0 participants
|
0 participants
|
|
Best Response
Partial Response
|
12 participants
|
11 participants
|
|
Best Response
Stable Disease
|
3 participants
|
4 participants
|
|
Best Response
Progressive Disease
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Serious Adverse Events (SAEs)
Febrile Neutropenia
|
2 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Haemolytic Anaemia
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Neutropenia
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Constipation
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Diarrhoea
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Gastrointestinal Perforation
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Haemorrhoids
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Vomiting
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Chest Pain
|
0 participants
|
2 participants
|
|
Serious Adverse Events (SAEs)
Asthenia
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Anaphylactic Reaction
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Drug Hypersensitivity
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Upper Respiratory Tract Infection
|
0 participants
|
2 participants
|
|
Serious Adverse Events (SAEs)
Cellulitis
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Pneumonia
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Tooth Infection
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Spinal Compression Fracture
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs)
Dehydration
|
1 participants
|
2 participants
|
|
Serious Adverse Events (SAEs)
Hypoglycaemi
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Syncope
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Pulmonary Embolism
|
1 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Epistaxis
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Hypoxia
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs)
Skin Ulcer
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Grade ≥ 3 Adverse Events (AEs)
Urinary Tract Infection
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Neutropenia
|
10 participants
|
2 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Leukopenia
|
7 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Febrile Neutropenia
|
3 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Haemolytic Anaemia
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Lymphopenia
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Diarrhoea
|
4 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Constipation
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Nausea
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Vomiting
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Gastrointestinal Perforation
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Haemorrhoids
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Small Intestinal Obstruction
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Fatigue
|
6 participants
|
2 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Chest Pain
|
0 participants
|
2 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Asthenia
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Mucosal Inflammation
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Hyperbilirubinaemia
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Drug Hypersensitivity
|
2 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Anaphylactic Reaction
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Upper Respiratory Tract Infection
|
0 participants
|
2 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Cellulitis
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Otitis Media
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Pneumonia
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Tooth Infection
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Spinal Compression Fracture
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Thermal Burn
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Haemoglobin Decreased
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Neutrophil Count Decreased
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Dehydration
|
1 participants
|
2 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Anorexia
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Hypoglycaemia
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Neuropathy Peripheral
|
1 participants
|
2 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Headache
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Migraine
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Syncope
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Haematuria
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Epistaxis
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Pulmonary Embolism
|
1 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0 participants
|
1 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Skin Ulcer
|
1 participants
|
0 participants
|
|
Grade ≥ 3 Adverse Events (AEs)
Hypertension
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Adverse Events Leading to Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Neutropenia
|
11 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Leukopenia
|
6 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Febrile Neutropenia
|
2 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Thrombocytopenia
|
2 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Lymphopenia
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Diarrhoea
|
4 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Nausea
|
2 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Vomiting
|
2 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Constipation
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Gastrointestinal Perforation
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Haemorrhoids
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Hyperbilirubinaemia
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Anaphylactic Reaction
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Drug Hypersensitivity
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Otitis Media
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Tooth Infection
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Spinal Compression Fracture
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Thermal Burn
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Anorexia
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Dehydration
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Neuropathy Peripheral
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Haematuria
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Skin Ulcer
|
1 participants
|
—
|
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Hypertension
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 Participants
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Neutropenia
|
9 participants
|
4 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Leukopenia
|
4 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Febrile Neutropenia
|
2 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Haemolytic Anaemia
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Lymphopenia
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Thrombocytopenia
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Diarrhoea
|
3 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Constipation
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Gastrointestinal Perforation
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Gingival Bleeding
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Nausea
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Small Intestinal Obstruction
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Toothache
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Vomiting
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Fatigue
|
3 participants
|
3 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Chest Pain
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Mucosal Inflammation
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Hyperbilirubinaemia
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Anaphylactic Reaction
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Otitis Media
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Pneumonia
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Rhinitis
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Skin Infection
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Upper Respiratory Tract Infection
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Thermal Burn
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Dehydration
|
1 participants
|
2 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Anorexia
|
1 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Hypoglycaemia
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Neuropathy Peripheral
|
1 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Memory Impairment
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Migraine
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Confusional State
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Haematuria
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Proteinuria
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Epistaxis
|
1 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Dyspnoea
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Haemoptysis
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Pulmonary Embolism
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Dermatitis
|
0 participants
|
1 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Skin Ulcer
|
1 participants
|
0 participants
|
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Hypertension
|
1 participants
|
0 participants
|
Adverse Events
Bevacizumab + Paclitaxel + Sunitinib
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Bevacizumab + Paclitaxel
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 participants at risk
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 participants at risk
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
8.7%
2/23
|
4.3%
1/23
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23
|
4.3%
1/23
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastrointestinal Perforatioin
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23
|
0.00%
0/23
|
|
General disorders
Chest Pain
|
0.00%
0/23
|
8.7%
2/23
|
|
General disorders
Asthenia
|
0.00%
0/23
|
4.3%
1/23
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/23
|
4.3%
1/23
|
|
Immune system disorders
Anaphylactic Reaction
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/23
|
8.7%
2/23
|
|
Immune system disorders
Cellulitis
|
0.00%
0/23
|
4.3%
1/23
|
|
Immune system disorders
Tooth Infection
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23
|
4.3%
1/23
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
4.3%
1/23
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/23
|
4.3%
1/23
|
|
Nervous system disorders
Syncope
|
0.00%
0/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.3%
1/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
4.3%
1/23
|
0.00%
0/23
|
Other adverse events
| Measure |
Bevacizumab + Paclitaxel + Sunitinib
n=23 participants at risk
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
|
Bevacizumab + Paclitaxel
n=23 participants at risk
Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
56.5%
13/23
|
21.7%
5/23
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.4%
7/23
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.3%
1/23
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
2/23
|
0.00%
0/23
|
|
Vascular disorders
Hypertension
|
8.7%
2/23
|
8.7%
2/23
|
|
Gastrointestinal disorders
Diarrhoea
|
17.4%
4/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23
|
0.00%
0/23
|
|
General disorders
Fatigue
|
34.8%
8/23
|
21.7%
5/23
|
|
Nervous system disorders
Neuropathy Peripheral
|
4.3%
1/23
|
8.7%
2/23
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Gingival Bleeding
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23
|
4.3%
1/23
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/23
|
4.3%
1/23
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Otitis Media
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Rhinitis
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Skin Infection
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/23
|
4.3%
1/23
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
4.3%
1/23
|
0.00%
0/23
|
|
Investigations
Hemoglobin Decreased
|
0.00%
0/23
|
4.3%
1/23
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/23
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
1/23
|
8.7%
2/23
|
|
Nervous system disorders
Headache
|
4.3%
1/23
|
0.00%
0/23
|
|
Nervous system disorders
Memory Impairment
|
4.3%
1/23
|
0.00%
0/23
|
|
Nervous system disorders
Migraine
|
0.00%
0/23
|
4.3%
1/23
|
|
Psychiatric disorders
Confusional State
|
4.3%
1/23
|
0.00%
0/23
|
|
Renal and urinary disorders
Hematuria
|
4.3%
1/23
|
0.00%
0/23
|
|
Renal and urinary disorders
Proteinuria
|
4.3%
1/23
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.0%
3/23
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/23
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/23
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/23
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysasthesia Syndrome
|
0.00%
0/23
|
4.3%
1/23
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.3%
1/23
|
0.00%
0/23
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Oral Discomfort
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Stomatitis
|
4.3%
1/23
|
0.00%
0/23
|
|
General disorders
Pain
|
0.00%
0/23
|
4.3%
1/23
|
|
General disorders
Pyrexia
|
0.00%
0/23
|
4.3%
1/23
|
|
Infections and infestations
Infection
|
0.00%
0/23
|
4.3%
1/23
|
|
Investigations
Weight Decreased
|
4.3%
1/23
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
4.3%
1/23
|
4.3%
1/23
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
4.3%
1/23
|
0.00%
0/23
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
1/23
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23
|
4.3%
1/23
|
Additional Information
Medical Communications Specialist
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.
- Publication restrictions are in place
Restriction type: OTHER