Pancreatic Cancer Research

Clinical trialPhase 1Recruiting

A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine

A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine in Subjects With Advanced Solid Tumors

NCT03854110↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Ongoing
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Start
14 January 2019
Expected end
30 September 2027
Enrollment
18 participants
Sites
4
Primary outcomes
Safety, tolerance and recommended misetionamide dose for subsequent studies in PROC
Sponsor
Industry
Results posted
No
Last update
19 October 2026

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Brief summary public domain (ClinicalTrials.gov)

This is a phase 1 dose escalation trial of monotherapy misetionamide (also known as GP-2250) currently enrolling patients with platinum-resistant ovarian cancer (PROC) into Part 2 of the study. Part 1 of the study evaluating misetionamide in combination with gemcitabine in subjects with advanced pancreatic cancer previously treated with 5-fluorouracil-based chemotherapy completed enrolment.

Detailed description public domain (ClinicalTrials.gov)

Part 2 of the trial will use a 3+3 dose escalation design. Subjects will continue to receive treatment until disease progression assessed by RECIST V1.1 criteria, clinical disease progression as assessed by the Investigator, unacceptable toxicity, subject request for withdrawal or lost to follow-up, Investigator assessment that risk outweighs benefit or study closure by the Sponsor. Part 2 will study PROC patients with disease progression within 6 months of the last dose of platinum-based chemotherapy and maximum of 2 prior regimens with at least one regimen causing the patient to meet the definition of platinum resistance.

Papers 2