Trial to Evaluate Safety and Tolerability of Misetionamide (GP-2250) in Combination With Gemcitabine

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Persevere Therapeutics Inc.
Study ID
NCT03854110
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • misetionamide (also known as GP-2250) — DRUG
    Part 2: misetionamide monotherapy for pharmacokinetics, safety, and tolerability.

Study Details

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.

Key Dates

First listed
Feb 26, 2019
Start date
Jan 14, 2019
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MIROC 1: Misetionamide Monotherapy in PROC
    Part 1 evaluated misetionamide for pancreatic cancer up to doses of 21 grams. Part 2 will evaluate misetionamide for PROC in doses of 30g with possible escalation to 40g administered weekly.

Primary Outcome Measure

Safety, tolerance and recommended misetionamide dose for subsequent studies in PROC

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60607
Amina Ahmed, MD
872-318-6760
University of Kansas Cancer CenterFairwayKansas66205
Anup Kasi, MD
[email protected]
913-568-4085
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Andrea Bullock, MD
[email protected]
617-667-2100
Abramson Cancer Center at the University of PennsylvaniaPhildelphiaPennsylvania19104
Mark O'Hara, MD
[email protected]
215-360-0919
Luda Mazaleuskaya, PhD
[email protected]
215-360-0919

Find similar trials in Chicago, IL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Rush University Medical Center· Chicago, ILUniversity of Kansas Cancer Center· Fairway, KSBeth Israel Deaconess Medical Center· Boston, MAAbramson Cancer Center at the University of Pennsylvania· Phildelphia, PA

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