Trial Outcomes & Findings for FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer (NCT NCT02641639)
NCT ID: NCT02641639
Last Updated: 2025-03-24
Results Overview
The primary efficacy parameter in this study is statistically meaningful PFS, defined as the time from the date of randomization until patient discontinuation or death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
12 Months
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
Fosbretabulin Tromethamine
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
36
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Fosbretabulin Tromethamine
n=34 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 8.05 • n=7 Participants
|
65 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Tumor Diameter Sum (cm)
|
80.1 cm
STANDARD_DEVIATION 64.17 • n=5 Participants
|
67.5 cm
STANDARD_DEVIATION 40.90 • n=7 Participants
|
73.7 cm
STANDARD_DEVIATION 53.44 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsThe primary efficacy parameter in this study is statistically meaningful PFS, defined as the time from the date of randomization until patient discontinuation or death from any cause.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=34 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Progression Free Survival
|
116.9 days
Interval 19.0 to 292.0
|
120.4 days
Interval 19.0 to 239.0
|
SECONDARY outcome
Timeframe: 12 MonthsImprovement in objective response rate (ORR). The ORR will be defined as the proportion of subjects with a confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1 criteria, based upon the best response. The ORR will be determined based on investigator assessment according to RECIST 1.1 criteria and/or GCIG CA-125 criteria.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=34 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Improvement in Objective Response Rate
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsEvaluation of overall survival (OS)
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=34 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Overall Survival (OS)
Censored
|
28 Participants
|
32 Participants
|
|
Overall Survival (OS)
Dies while on study
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsAssessment of the proportion of subjects who remain progression-free at 12 months on the regimen of PCC plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=34 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Proportion of Subjects Who Remain Progression-free at 12 Months
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsTo evaluate the Incidence of Treatment-Emergent Adverse Events of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo as measured by aggregate reporting of the number of patient with abnormal findings on (physical exams, vital signs, laboratory measures, ECG, Eastern Cooperative Oncology Group (ECOG) performance status (PS)) and/or analysis of the incidence of adverse events (AEs) using the National Cancer Institute (NCI)-Common Terminology Criteria for AEs (CTCAE) version 4.03.
Outcome measures
| Measure |
Fosbretabulin Tromethamine
n=34 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 Participants
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of PCC Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo
|
28 Participants
|
30 Participants
|
Adverse Events
Fosbretabulin Tromethamine
Serious events: 10 serious events
Other events: 28 other events
Deaths: 6 deaths
Placebo
Serious events: 11 serious events
Other events: 30 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Fosbretabulin Tromethamine
n=34 participants at risk
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 participants at risk
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
2.9%
1/34 • 1 year, 3 months
MedDRA System Organ Class
|
2.8%
1/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Eye disorders
Gastrointestinal disorders
|
8.8%
3/34 • 1 year, 3 months
MedDRA System Organ Class
|
8.3%
3/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Infections and infestations
Infections and infestations
|
8.8%
3/34 • 1 year, 3 months
MedDRA System Organ Class
|
13.9%
5/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
8.8%
3/34 • 1 year, 3 months
MedDRA System Organ Class
|
2.8%
1/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Psychiatric disorders
Psychiatric disorders
|
5.9%
2/34 • 1 year, 3 months
MedDRA System Organ Class
|
0.00%
0/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
8.8%
3/34 • 1 year, 3 months
MedDRA System Organ Class
|
2.8%
1/36 • 1 year, 3 months
MedDRA System Organ Class
|
Other adverse events
| Measure |
Fosbretabulin Tromethamine
n=34 participants at risk
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and CA4P
Fosbretabulin tromethamine: CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
|
Placebo
n=36 participants at risk
Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin \[PLD\]) plus bevacizumab and placebo
Placebo: Saline for infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
4/34 • 1 year, 3 months
MedDRA System Organ Class
|
11.1%
4/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Gastrointestinal disorders
Constipation
|
17.6%
6/34 • 1 year, 3 months
MedDRA System Organ Class
|
11.1%
4/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
4/34 • 1 year, 3 months
MedDRA System Organ Class
|
19.4%
7/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Gastrointestinal disorders
Nausea
|
32.4%
11/34 • 1 year, 3 months
MedDRA System Organ Class
|
19.4%
7/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Gastrointestinal disorders
Stomatitis
|
14.7%
5/34 • 1 year, 3 months
MedDRA System Organ Class
|
13.9%
5/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
General disorders
Fatigue
|
32.4%
11/34 • 1 year, 3 months
MedDRA System Organ Class
|
27.8%
10/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
General disorders
Edema peripheral
|
11.8%
4/34 • 1 year, 3 months
MedDRA System Organ Class
|
16.7%
6/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
2/34 • 1 year, 3 months
MedDRA System Organ Class
|
11.1%
4/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Nervous system disorders
Headache
|
20.6%
7/34 • 1 year, 3 months
MedDRA System Organ Class
|
25.0%
9/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.8%
3/34 • 1 year, 3 months
MedDRA System Organ Class
|
13.9%
5/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
1/34 • 1 year, 3 months
MedDRA System Organ Class
|
11.1%
4/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
14.7%
5/34 • 1 year, 3 months
MedDRA System Organ Class
|
25.0%
9/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Vascular disorders
Hot flush
|
8.8%
3/34 • 1 year, 3 months
MedDRA System Organ Class
|
11.1%
4/36 • 1 year, 3 months
MedDRA System Organ Class
|
|
Vascular disorders
Hypertension
|
38.2%
13/34 • 1 year, 3 months
MedDRA System Organ Class
|
33.3%
12/36 • 1 year, 3 months
MedDRA System Organ Class
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place