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NCT03337087 · ClinicalTrials.gov registry record · Phase 1
Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Metastatic Colorectal Carcinoma, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT03337087: Active Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Metastatic Colorectal Carcinoma, sponsored by Academic and Community Cancer Research United.
NCT03337087 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Metastatic Colorectal Carcinoma that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 18 participants, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03337087, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Metastatic Colorectal Carcinoma, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as liposomal irinotecan, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as rucaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Giving liposomal irinotecan and rucaparib together with fluorouracil and leucovorin calcium may work better in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer.
Conditions Studied
Interventions
- DRUG Fluorouracil
- OTHER Laboratory Biomarker Analysis
- DRUG Leucovorin Calcium
- DRUG Irinotecan Sucrosofate
- DRUG Rucaparib
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-11-02 |
| Est. Completion | 2025-08-09 |
| Phase | Phase 1 |
What the registry record for NCT03337087 still lists
NCT03337087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (80% lower).
The record links to 9 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT03337087 reports a single indexed study location in Arizona, Georgia, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03337087 about?
NCT03337087 is a clinical study titled "Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer". This phase I/II trial studies the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other...
What is the current status of trial NCT03337087?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-11-02. Estimated completion is 2025-08-09.
What conditions does trial NCT03337087 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Metastatic Colorectal Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage IV Colorectal Cancer AJCC v7.
What interventions are being tested in trial NCT03337087?
The interventions under investigation include: Fluorouracil (DRUG), Laboratory Biomarker Analysis (OTHER), Leucovorin Calcium (DRUG), Irinotecan Sucrosofate (DRUG), Rucaparib (DRUG).
Who is sponsoring clinical trial NCT03337087?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03337087 being conducted?
This trial has 3 study locations across Arizona, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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