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Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
NCT03854110 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03854110
The ClinicalTrials.gov registry entry for NCT03854110 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Geistlich Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03854110 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Kansas, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03854110?
The interventions under investigation include: GP-2250 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03854110?
This trial is sponsored by Geistlich Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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