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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279602
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mateon Therapeutics

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: fosbretabulin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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
Other Name: CA4P, combretastatin A-4 phosphate




Primary Outcome Measures :
  1. Change in biomarkers from baseline [ Time Frame: 48 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279602


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Kentucky
Markey Cancer Center, Clinical Research Office
Lexington, Kentucky, United States, 40356
United States, New York
Montefiore
Bronx, New York, United States, 10467
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Wisconsin
Froedtert Hospital, Medicial College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Mateon Therapeutics

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Responsible Party: Mateon Therapeutics
ClinicalTrials.gov Identifier: NCT02279602    
Other Study ID Numbers: OX4219s
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Mateon Therapeutics:
Pancreatic
Gastrointestional
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Fosbretabulin
Combretastatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action