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

NCT ID: NCT02279602

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

fosbretabulin

Intervention Type DRUG

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

Interventions

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fosbretabulin

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

Intervention Type DRUG

Other Intervention Names

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CA4P, combretastatin A-4 phosphate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mateon Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Markey Cancer Center, Clinical Research Office

Lexington, Kentucky, United States

Site Status

Montefiore

The Bronx, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Froedtert Hospital, Medicial College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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OX4219s

Identifier Type: -

Identifier Source: org_study_id

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