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Completed

NCT Number: NCT02279602

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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fosbretabulin

Drug

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

Other names: CA4P, combretastatin A-4 phosphate

Primary outcomes

  1. Change in biomarkers from baseline

    Time frame: 48 Weeks

Sponsors and collaborators

Lead sponsor

Mateon Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2014
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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