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

Mateon Therapeutics

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Drug: fosbretabulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02279602

OX4219s

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Single Arm

Experimental group

Description:

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

Treatment:

Drug: fosbretabulin