Back to resultsRollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fosbretabulin
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Pancreatic, Gastrointestional
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
Sites / Locations
- Stanford University School of Medicine
- Markey Cancer Center, Clinical Research Office
- Montefiore
- Duke University Medical Center
- Froedtert Hospital, Medicial College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s
Outcomes
Primary Outcome Measures
Change in biomarkers from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02279602
Brief Title
Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mateon Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Pancreatic, Gastrointestional
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s
Intervention Type
Drug
Intervention Name(s)
fosbretabulin
Other Intervention Name(s)
CA4P, combretastatin A-4 phosphate
Intervention Description
fosbretabullin, 60 mg/m2 weekly for up to 1 year
Primary Outcome Measure Information:
Title
Change in biomarkers from baseline
Time Frame
48 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Markey Cancer Center, Clinical Research Office
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40356
Country
United States
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Froedtert Hospital, Medicial College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
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