Trial Outcomes & Findings for Bevacizumab and Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma (NCT NCT00387751)

Results Overview

Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

4 months

Results posted on

2017-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab and Sorafenib
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab and Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab and Sorafenib n=14 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Bevacizumab and Sorafenib n=14 Participants Bevacizumab was administered as a 5 mg/kg intravenous dose every 2 weeks. The dose was based on the patient's actual body weight; the dose recalculated if there was a weight change of \>10% from baseline. Sorafenib was administered as a 200 mg oral dose twice daily, for 5 days every 7 days. Courses will be defined as 28-day treatment periods and will be repeated without interruption until development of progressive disease or development of serious drug related toxicities.
Response	11 participants

SECONDARY outcome

Timeframe: 6 months

Population: Data were not collected

Safety and tolerability of treatment, in terms of toxicity profile and incidence and rating of toxicity, according to NCI CTCAE v3.0 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Data were not collected

Determined by time to progression, progression-free suvival, and overall survival.

Outcome measures

Outcome data not reported

Adverse Events

Bevacizumab and Sorafenib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Sarantopoulos

University of Texas Health Science Center at San Antonio

Phone: 210-450-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60