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NCT01494506 · ClinicalTrials.gov registry record · Phase 3
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
A Phase 3 study, sponsored by Merrimack Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 417
- Enrollment target
NCT01494506: Completed Phase 3 study, sponsored by Merrimack Pharmaceuticals.
NCT01494506 is a Phase 3 study that has completed, run by Merrimack Pharmaceuticals. The registered enrollment target is 417 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01494506, a Phase 3 study, has completed, sponsored by Merrimack Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 417 participants
- Enrollment target
Study Summary
The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.
Primary Outcome
Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients wh
Interventions
- DRUG Leucovorin
- DRUG 5 Fluorouracil
- DRUG MM-398
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT01494506 record still lists
NCT01494506 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Leucovorin is the first listed.
NCT01494506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01494506 about?
NCT01494506 is a clinical study titled "Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer". The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.
What is the current status of trial NCT01494506?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2011-11. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01494506?
The interventions under investigation include: Leucovorin (DRUG), 5 Fluorouracil (DRUG), MM-398 (DRUG).
Who is sponsoring clinical trial NCT01494506?
This trial is sponsored by Merrimack Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01494506's enrollment target sits among peer trials
417 902nd of 2000 higher than 1,099 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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