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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
Subjects should be eligible to receive gemcitabine monotherapy for the treatment of their pancreatic cancer per the judgment of the Investigator.
Male and female subjects age > 18 years at the time of trial entry.
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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My doctor agrees I can be treated with gemcitabine for my pancreatic cancer.
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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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I am a woman who can have children and I have a negative pregnancy test.
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My pancreatic cancer cannot be removed by surgery and has spread.
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I have had brain metastasis treatment and have been stable without symptoms for 4 weeks.
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I agree to use effective birth control and not donate sperm for 3 months after my last treatment.
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My organ functions are within normal ranges according to recent tests.
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My cancer got worse while on or soon after finishing 5-FU chemotherapy.
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I am not pregnant or breastfeeding and, if capable of becoming pregnant, I agree to use contraception during and for 3 months after treatment.

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.

Find a Location

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
956 Total Patients Enrolled
Anup Kasi, MDStudy ChairUniversity of Kansas
2 Previous Clinical Trials
68 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide a summary of the empirical research done on GP-2250?

"Presently, 446 studies are taking place to research GP-2250 with 134 of those trials being in the final phase. While most of these study locations are based in Woolloongabba, Queensland, there is a total of 24565 sites running experiments for this particular treatment."

Answered by AI

What is the scope of recruitment for this clinical experiment?

"Affirmative, clinicaltrials.gov reports that this research endeavour is currently recruiting participants. This trial was initiated on the 14th of January 2019 and has been edited as recently as 12th January 2022. A total of 64 patients need to be assigned across 8 locations for this experiment to commence."

Answered by AI

How many venues are offering this trial at the present?

"This trial is run at eight different sites, including Quest Research Institute in Farmington Hills and Karmanos Cancer Institute in Detroit. Additionally, Allina Health Winston-Salem will be involved along with five other medical centres."

Answered by AI

To what degree might GP-2250 affect patients' health adversely?

"GP-2250's safety rating is a 1, given the paucity of evidence concerning its efficacy and protection from adverse effects. This assessment was made by our team at Power due to it being classified as a Phase 1 trial."

Answered by AI

What has GP-2250 been demonstrated to be effective for?

"GP-2250 is typically given to patients with small cell lung cancer (SCLC) but has also been used to address head and neck carcinoma, advanced pancreatic adenocarcinomas, as well as cervical cancers."

Answered by AI

Are there still opportunities for participants to join in on this research project?

"According to the clinicaltrials.gov portal, this medical trial is open for recruitment with an initial date of posting on January 14th 2019 and a recent edition made on January 12th 2022."

Answered by AI
~6 spots leftby Sep 2024