GP-2250 + Gemcitabine for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+8 other 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.

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

I am older than 18 years.

I am fully active or can carry out light work.

My pancreatic cancer cannot be removed by surgery and has spread.

Exclusion Criteria

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

I have lung issues, heart disease, or severe allergies.

I have a history or current signs of bleeding in the eye or glaucoma.

I haven't had cancer treatment or surgery within the last 3 to 6 weeks.

I have a history of sickle cell disease or a similar inherited anemia.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: GP-2250 MonotherapyExperimental Treatment1 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.