Rollover Protocol For Subjects Who Have Responded On Study 4218s - A Phase 2 Study

Study Overview

Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study

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.

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.

Neuroendocrine Tumors

DRUG: fosbretabulin

OX4219s

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-10-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-04-13
First Submitted that Met QC Criteria 2014-10-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-04-17
First Posted (ACTUAL) 2014-10-31	Results First Posted N/A	Last Verified 2018-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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	DRUG: fosbretabulin fosbretabullin, 60 mg/m2 weekly for up to 1 year

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Single Arm

Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s

DRUG: fosbretabulin

fosbretabullin, 60 mg/m2 weekly for up to 1 year

Primary Outcome Measures	Measure Description	Time Frame
Change in biomarkers from baseline		48 Weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s

Subject has not received fosbretabulin treatment in the study OX4218s

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record