A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine
NCT03854110 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-07-23
Summary
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.
Conditions
Interventions
- DRUG
-
misetionamide (also known as GP-2250)
Part 2: misetionamide monotherapy for pharmacokinetics, safety, and tolerability.
Sponsors & Collaborators
-
Translational Drug Development
collaborator OTHER -
Persevere Therapeutics Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-14
- Primary Completion
- 2027-07-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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