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.
Brief Title
Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Neuroendocrine Tumors
Eligibility Criteria
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
* Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
Exclusion Criteria:
* Subject has not received fosbretabulin treatment in the study OX4218s
Inclusion Criteria
Inclusion Criteria:
* Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
* Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
Gender
All
Gender Based
false
Keywords
Pancreatic
Gastrointestional
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02279602
Org Class
Industry
Org Full Name
Mateon Therapeutics
Org Study Id
OX4219s
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Measure
Change in biomarkers from baseline
Outcome Time Frame
48 Weeks
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Libutti
Investigator Email
slibutti@montefiore.org
Investigator Phone