Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2014 |
| End Date: | December 2016 |
Rollover for Study OX4218s, A P2 Study to Investigate Safety and Activity of Fosbretabulin Tromethamine in the Treatment of Well-Differentiated, Low-to-Intermediate-Grade Unresectable, Recurrent or Metastatic PNET or GI-NET With Elevated Biomarkers
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.
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.
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.
Inclusion Criteria:
- Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
Exclusion Criteria:
- Subject has not received fosbretabulin treatment in the study OX4218s
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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