GP-2250 + Gemcitabine for Pancreatic Cancer

Recruiting at8 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Geistlich Pharma AG

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, GP-2250, combined with gemcitabine for patients with advanced pancreatic cancer who haven't responded to other treatments. The goal is to see if this combination works better than existing options. Gemcitabine has been widely used in the treatment of advanced pancreatic cancer, often in combination with other drugs to improve results.

Research Team

Anup Kasi, MD

Principal Investigator

University of Kansas

Eligibility Criteria

Adults over 18 with advanced pancreatic cancer that's unremovable or has spread, and who've had certain previous chemotherapies can join. They need a measurable tumor, good blood counts, organ function, and must use effective birth control. Exclusions include recent other cancers (except some skin/breast/cervical), heart disease, lung conditions, major surgery within the last month, or COVID-19 recently.

Inclusion Criteria

- Aspartate aminotransferase (AST), (Serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT), and (Serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastasis

- International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN

My doctor agrees I can be treated with gemcitabine for my pancreatic cancer.

Exclusion Criteria

I have not had major surgery, except for a biopsy, in the last 4 weeks.

First degree relative of the investigator, study staff or the sponsor.

I have only been diagnosed with pancreatic cancer in the last 2 years, except for certain skin, breast, or cervical cancers treated to cure.

Treatment Details

Interventions

• GP-2250 (Other)

Trial Overview The trial is testing GP-2250 combined with gemcitabine in patients who have previously been treated with fluorouracil-based chemotherapy for their pancreatic cancer. It's a phase 1 trial to see what doses are safe and how well patients tolerate this combination treatment.

Participant Groups

Group I: GP-2250 Monotherapy Experimental Treatment 1 Intervention

GP-2250 in doses of 250 mg up to 30 grams intravenously on Days -7, 1, 8, 15 (Cycle 1) and Cycle 2 and all subsequent cycles on Days 7, 8, 15 of a 28-day cycle with gemcitabine 1000 mg/m2 on Days 1, 8, 15 days of the cycle.

Who Is Running the Clinical Trial?

Geistlich Pharma AG

Lead Sponsor

Trials

45

Recruited

2,300+

Translational Drug Development

Collaborator

Trials

19

Recruited

1,000+