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

NCT03854110 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-09-11

No results posted yet for this study

Summary

This is a phase 1 first in human, dose escalation trial of GP-2250 administered in combination with gemcitabine in subjects with advanced pancreatic cancer previously treated with 5-fluorouracil-based chemotherapy.

Prior radiosensitization with gemcitabine, the use of 5-fluorouracil, FOLFIRINOX or Nab-paclitaxel/gemcitabine in the neoadjuvant setting, and prior pancreaticoduodenectomy (Whipple procedure) is allowed. If prior treatment with gemcitabine was at therapeutic doses, a minimum of 3 months must have elapsed since the end of such treatment.

As a precursor to 5-FU use of capecitabine-based chemotherapy is also permitted.

Conditions

  • Pancreatic Cancer, Adult

Interventions

DRUG

GP-2250

GP-2250 monotherapy for pharmacokinetics and safety; GP-2250 plus gemcitabine for safety, tolerability, pharmacokinetics, and biomarker assessments

Sponsors & Collaborators

  • Translational Drug Development

    collaborator OTHER

  • Geistlich Pharma AG

    lead INDUSTRY

Principal Investigators

  • Anup Kasi, MD · University of Kansas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854110 on ClinicalTrials.gov