Tumors
Conditions
Keywords
non-small cell lung cancer, non-small cell lung carcinoma, neoplasms, lung, lung cancer, tumors, NSCLC
Brief summary
The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus CA4P. The rationale for this study is the potential additive or synergistic actions of vascular disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.
Detailed description
Lung cancer has become the leading cause of cancer death in both men and women in the US and Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment is available for advanced stages of the disease (stages III and IV), which comprise the majority of cases. Treatment with the combination of carboplatin and paclitaxel has been shown to be effective and well tolerated in advanced stage NSCLC. Targeted therapies, such as bevacizumab, often act synergistically with chemotherapy. Bevacizumab inhibits vascular endothelial growth factor (VEGF), necessary for endothelial cell proliferation and new blood vessel formation. CA4P targets existing abnormal vasculature of tumors, impeding tumor blood flow and leading to extensive tumor cell death as a consequence of oxygen and nutrient deprivation. This study will compare the effect of CA4P when combined with chemotherapy and bevacizumab on progression free survival (PFS) to PFS after chemotherapy and bevacizumab alone.
Interventions
DRUGFosbretabulin
Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
DRUGCarboplatin
Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
DRUGPaclitaxel
Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
DRUGBevacizumab
Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
Sponsors
Mateon Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed Stage IIIB NSCLC with malignant pleural effusion, or Stage IV disease * Measurable disease on CT scan (by the Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 (which means able to independently care for self and to perform light work) . * Adequate blood counts * Adequate liver and kidney function * Subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
Exclusion criteria
* Predominant Squamous Cell NSCLC histology. * History of treatment for NSCLC with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted) * Brain (CNS) metastasis by head CT scan or MRI * Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (PSA) of \< 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and \>2 year disease free interval may be entered after discussion with the Medical Monitor. * History of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months * Certain cardiac disorders such as recent myocardial infarction (MI), severe congestive heart failure, certain types of abnormal cardiac rhythm * Uncontrolled high blood pressure despite medications * Uncontrolled, clinically significant active infection. * Known HIV * Known hypersensitivity to any of the components of CA4P, paclitaxel, carboplatin, bevacizumab, or radiologic contrast dyes. Details of the above and additional inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) in the Intent-to-Treat Population | Six 21-day cycles | Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Six 21-day cycles | Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD. |
| Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population | Until death or lost to follow-up, up to 12 months since randomization | — |
| Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Days 1 (pretreatment) per 21-day Cycle (6 Cycles) | — |
| Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles) | — |
| Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | Day 1 (pretreatment) per 21-day Cycle (6 Cycles) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Chemotherapy+Bevacizumab Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles. | 29 |
| Arm 2: Active Comparator+Fosbretabulin Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles. | 31 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Disease Progression | 2 | 3 |
| Overall Study | Other | 2 | 6 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Arm 1: Chemotherapy+Bevacizumab | Total | Arm 2: Active Comparator+Fosbretabulin |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 9.5 | 62.2 years STANDARD_DEVIATION 9.5 | 61.0 years STANDARD_DEVIATION 9.4 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - Fully active | 16 participants | 32 participants | 16 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 - Restricted in physically strenuous activity | 13 participants | 28 participants | 15 participants |
| Prior Radiation Due to NSCLC No | 25 participants | 52 participants | 27 participants |
| Prior Radiation Due to NSCLC Yes | 4 participants | 8 participants | 4 participants |
| Prior Surgery Due to NSCLC No | 26 participants | 55 participants | 29 participants |
| Prior Surgery Due to NSCLC Yes | 3 participants | 5 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) White | 23 Participants | 50 Participants | 27 Participants |
| Region of Enrollment United States | 29 participants | 60 participants | 31 participants |
| Sex: Female, Male Female | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Male | 12 Participants | 31 Participants | 19 Participants |
| Stage of Disease at Study Entry IIIB | 4 participants | 6 participants | 2 participants |
| Stage of Disease at Study Entry IV | 25 participants | 54 participants | 29 participants |
| Subject Given Radiation Therapy Information Missing | 1 participants | 1 participants | 0 participants |
| Subject Given Radiation Therapy No | 23 participants | 50 participants | 27 participants |
| Subject Given Radiation Therapy Yes | 5 participants | 9 participants | 4 participants |
| Surgery Performed No | 24 participants | 51 participants | 27 participants |
| Surgery Performed Yes | 5 participants | 9 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 29 | 31 / 31 |
| serious Total, serious adverse events | 16 / 29 | 16 / 31 |
Outcome results
Primary
Progression Free Survival (PFS) in the Intent-to-Treat Population
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.
Time frame: Six 21-day cycles
Population: Intent-to-Treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Progression Free Survival (PFS) in the Intent-to-Treat Population | 9.3 months |
| Arm 2: Active Comparator+Fosbretabulin | Progression Free Survival (PFS) in the Intent-to-Treat Population | 8.6 months |
Secondary
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.
Time frame: Six 21-day cycles
Population: Intent-to-Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Complete Response | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Progressive Disease | 3 participants |
| Arm 1: Chemotherapy+Bevacizumab | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Stable Disease | 13 participants |
| Arm 1: Chemotherapy+Bevacizumab | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Unknown | 4 participants |
| Arm 1: Chemotherapy+Bevacizumab | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Partial Response | 11 participants |
| Arm 2: Active Comparator+Fosbretabulin | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Unknown | 5 participants |
| Arm 2: Active Comparator+Fosbretabulin | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Complete Response | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Stable Disease | 8 participants |
| Arm 2: Active Comparator+Fosbretabulin | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Progressive Disease | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population | Partial Response | 18 participants |
Secondary
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Time frame: Days 1 (pretreatment) per 21-day Cycle (6 Cycles)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Total Bilirubin - Grade 4 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALT - Grade 4 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | AST - Grade 3 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | AST - Grade 4 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Glucose - Grade 4 | 1 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Creatinine - Grade 3 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Creatinine - Grade 4 | 1 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Calcium - Grade 3 | 3 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Calcium - Grade 4 | 1 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Potassium - Grade 3 | 5 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Potassium - Grade 4 | 1 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Sodium - Grade 3 | 5 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Sodium - Grade 4 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALP - Grade 3 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALP - Grade 4 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Total Bilirubin - Grade 3 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALT - Grade 3 | 1 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Glucose - Grade 3 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Magnesium - Grade 3 | 2 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Magnesium - Grade 4 | 2 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Phosphorus - Grade 3 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Phosphorus - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Potassium - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALT - Grade 3 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Magnesium - Grade 3 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALT - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Sodium - Grade 3 | 2 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | AST - Grade 3 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Total Bilirubin - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | AST - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Glucose - Grade 3 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Sodium - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Glucose - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Phosphorus - Grade 3 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Creatinine - Grade 3 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALP - Grade 3 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Creatinine - Grade 4 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Calcium - Grade 4 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Calcium - Grade 3 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | ALP - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Phosphorus - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Magnesium - Grade 4 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Potassium - Grade 3 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population) | Total Bilirubin - Grade 3 | 0 participants |
Secondary
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
Time frame: Day 1 (pretreatment) per 21-day Cycle (6 Cycles)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | INR - Grade 3 | 2 participants |
| Arm 1: Chemotherapy+Bevacizumab | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | INR - Grade 4 | 0 participants |
| Arm 1: Chemotherapy+Bevacizumab | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | PTT - Grade 3 | 3 participants |
| Arm 1: Chemotherapy+Bevacizumab | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | PTT - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | PTT - Grade 4 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | INR - Grade 3 | 3 participants |
| Arm 2: Active Comparator+Fosbretabulin | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | PTT - Grade 3 | 5 participants |
| Arm 2: Active Comparator+Fosbretabulin | Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population) | INR - Grade 4 | 0 participants |
Secondary
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Time frame: Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Hemoglobin - Grade 3 | 7 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Platelets - Grade 3 | 3 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Platelets - Grade 4 | 6 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Hemoglobin - Grade 4 | 4 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | White Blood Cell - Grade 3 | 14 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | White Blood Cell - Grade 4 | 2 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Absolute Neutrophils - Grade 3 | 4 participants |
| Arm 1: Chemotherapy+Bevacizumab | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Absolute Neutrophils - Grade 4 | 20 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Hemoglobin - Grade 4 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Hemoglobin - Grade 3 | 0 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Absolute Neutrophils - Grade 4 | 20 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | White Blood Cell - Grade 4 | 1 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Platelets - Grade 3 | 5 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | White Blood Cell - Grade 3 | 12 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Platelets - Grade 4 | 3 participants |
| Arm 2: Active Comparator+Fosbretabulin | Hematology NCI-CTCAE Grade 3 or 4 (Safety Population) | Absolute Neutrophils - Grade 3 | 5 participants |
Secondary
Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population
Time frame: Until death or lost to follow-up, up to 12 months since randomization
Population: Intent-to-Treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population | 16.2 Months |
| Arm 2: Active Comparator+Fosbretabulin | Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population | 13.6 Months |