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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
fosbretabullin, 60 mg/m2 weekly for up to 1 year
Stanford University School of Medicine
Stanford, California, United States
Markey Cancer Center, Clinical Research Office
Lexington, Kentucky, United States
Montefiore
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Change in biomarkers from baseline
Time frame: 48 Weeks
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Froedtert Hospital, Medicial College of Wisconsin
Milwaukee, Wisconsin, United States