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

Neuroendocrine Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279602
• Other study ID #: OX4219s
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2014
• Last updated: April 13, 2018
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: April 2018
• Source: Mateon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore	Bronx	New York
United States	Duke University Medical Center	Durham	North Carolina
United States	Markey Cancer Center, Clinical Research Office	Lexington	Kentucky
United States	Froedtert Hospital, Medicial College of Wisconsin	Milwaukee	Wisconsin
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Mateon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarkers from baseline		48 Weeks