Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
- Registration Number
- NCT02279602
- Lead Sponsor
- Mateon Therapeutics
- Brief Summary
Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.
- Detailed Description
Subjects enrolled in the PNET/GI-NET study OX4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. Subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol OX4219s). Subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
- Subject has not received fosbretabulin treatment in the study OX4218s
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm fosbretabulin Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s
- Primary Outcome Measures
Name Time Method Change in biomarkers from baseline 48 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Froedtert Hospital, Medicial College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Montefiore
🇺🇸Bronx, New York, United States
Markey Cancer Center, Clinical Research Office
🇺🇸Lexington, Kentucky, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States