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NCT03854110 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
A Phase 1 study of Pancreatic Cancer, Adult, sponsored by Geistlich Pharma.
- Active
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 5
- Study locations
NCT03854110: Active Phase 1 study of Pancreatic Cancer, Adult, sponsored by Geistlich Pharma.
NCT03854110 is a Phase 1 study of Pancreatic Cancer, Adult that is active but no longer recruiting, run by Geistlich Pharma. The registered enrollment target is 64 participants, below the 489-participant average among 3 other Pancreatic Cancer, Adult trials with a reported enrollment target (87% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03854110, a Phase 1 study of Pancreatic Cancer, Adult, is active but no longer recruiting, sponsored by Geistlich Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Evaluation of Adverse Events (AEs), Serious AEs (SAEs), physical exam, vital signs, ECG, ECOG score, clinical labs.
Conditions Studied
Interventions
- DRUG GP-2250
Study Locations (5)
California
- Hoag Family Cancer Institute - Newport Beach
Kansas
- University of Kansas Cancer Center - Fairway
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Pennsylvania
- Abramson Cancer Center at the University of Pennsylvania - Phildelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03854110 still lists
NCT03854110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 489-participant average among 3 other Pancreatic Cancer, Adult trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Pancreatic Cancer, Adult appearing as the primary indexed condition, and to 1 intervention - of which GP-2250 is the first listed.
NCT03854110 lists 5 locations in 5 states (California, Kansas, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03854110 about?
NCT03854110 is a clinical study titled "Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine". 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 ...
What is the current status of trial NCT03854110?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2019-01-14. Estimated completion is 2026-06-30.
What conditions does trial NCT03854110 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Adult.
What interventions are being tested in trial NCT03854110?
The interventions under investigation include: GP-2250 (DRUG).
Who is sponsoring clinical trial NCT03854110?
This trial is sponsored by Geistlich Pharma, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03854110 being conducted?
This trial has 5 study locations across California, Kansas, Massachusetts, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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