- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279602
Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
April 13, 2018 updated by: Mateon Therapeutics
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Kentucky
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Lexington, Kentucky, United States, 40356
- Markey Cancer Center, Clinical Research Office
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New York
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Bronx, New York, United States, 10467
- Montefiore
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital, Medicial College of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s
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fosbretabullin, 60 mg/m2 weekly for up to 1 year
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in biomarkers from baseline
Time Frame: 48 Weeks
|
48 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
October 29, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Actual)
April 17, 2018
Last Update Submitted That Met QC Criteria
April 13, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Fosbretabulin
- Combretastatin
Other Study ID Numbers
- OX4219s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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