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Thymogen

Glu-Trp, EW dipeptide, Oglufanide, L-Glutamyl-L-tryptophan

Quick Stats
Studies 94
Trials 51
Completed PHASE1 INTERVENTIONAL NCT00003773

IM-862 in Treating Patients With Recurrent Ovarian Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have recurrent ovarian cancer after treatment with chemotherapy and surgery.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of IM-862 administered intranasally in patients with recurrent ovarian cancer. II. Determine the toxicity of this regimen in this patient population. III. Obtain preliminary data regarding the efficacy of this drug in these patients. IV. Evaluate the effect of this drug in serum levels of vascular endothelial growth factor and transforming growth factor in this population. OUTLINE: This is a dose escalation study. Patients receive IM-862 intranasally daily. Treatment continues for 6 months in the absence of unacceptable toxicity or disease progression. At the physician's discretion, further treatment may be given if the patient is still responding after 6 months of treatment. The dose of IM-862 is escalated in cohorts of 10-20 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A total of 20-70 evaluable patients will be accrued for this study within 6-9 months.

Interventions

Name: oglufanide disodium
Type: DRUG
Description:

Trial Information

NCT ID

NCT00003773

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

University of Southern California

Last Updated

December 15, 2025