Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
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
1 other identifier
interventional
7
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedApril 17, 2018
April 1, 2018
1.7 years
October 29, 2014
April 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in biomarkers from baseline
48 Weeks
Study Arms (1)
Single Arm
EXPERIMENTALSubjects will receive fosbretabulin at the same dose and frequency as in study OX4218s
Interventions
fosbretabullin, 60 mg/m2 weekly for up to 1 year
Eligibility Criteria
You may qualify if:
- Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
You may not qualify if:
- Subject has not received fosbretabulin treatment in the study OX4218s
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Stanford University School of Medicine
Stanford, California, 94305, United States
Markey Cancer Center, Clinical Research Office
Lexington, Kentucky, 40356, United States
Montefiore
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Froedtert Hospital, Medicial College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
December 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 17, 2018
Record last verified: 2018-04