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GP-2250 + Gemcitabine for Pancreatic Cancer

Phase 1
Recruiting
Research Sponsored by Geistlich Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects age > 18 years at the time of trial entry.
Subjects must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 months
Awards & highlights

Study Summary

This trial is for people with pancreatic cancer who have never been treated with gemcitabine before.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since it's an early-phase trial for GP-2250 plus gemcitabine after specific prior treatments, detailed side effects aren't listed but may include typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am fully active or can carry out light work.
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My pancreatic cancer cannot be removed by surgery and has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Carbohydrate Antigen 19-9 (CA-19-9)
Effect on disease

Trial Design

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.

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Who is running the clinical trial?

Geistlich Pharma AGLead Sponsor
41 Previous Clinical Trials
2,012 Total Patients Enrolled
Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
948 Total Patients Enrolled
Anup Kasi, MDStudy ChairUniversity of Kansas
2 Previous Clinical Trials
68 Total Patients Enrolled
~4 spots leftby Sep 2024
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