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NCT01835041 · ClinicalTrials.gov registry record · Phase 1
CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01835041: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT01835041 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01835041, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of CPI-613 when given together with combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Primary Outcome
of 6,8-bis(benzylthio)octanoic acid when used in combination with mFOLFIRINOX determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
- DRUG 6,8-bis(benzylthio)octanoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-04 |
| Est. Completion | 2023-03-16 |
| Phase | Phase 1 |
What the finished NCT01835041 record still lists
NCT01835041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT01835041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01835041 about?
NCT01835041 is a clinical study titled "CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer". This phase I trial studies the side effects and best dose of CPI-613 when given together with combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in dif...
What is the current status of trial NCT01835041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2013-04. Estimated completion is 2023-03-16.
What interventions are being tested in trial NCT01835041?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG), 6,8-bis(benzylthio)octanoic acid (DRUG).
Who is sponsoring clinical trial NCT01835041?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01835041's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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