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NCT01621243 · ClinicalTrials.gov registry record · Phase 1
M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
A Phase 1 study, sponsored by Momenta Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
NCT01621243: Clinical Trial Phase 1 study, sponsored by Momenta Pharmaceuticals.
NCT01621243 is a Phase 1 study that was terminated before completion, run by Momenta Pharmaceuticals. The registered enrollment target is 128 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621243, a Phase 1 study, was terminated before completion, sponsored by Momenta Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
Study Summary
People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies to have anti-cancer effects. Necuparanib has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether necuparanib administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.
Primary Outcome
At baseline and then each of 6 visits after the start of dosing in a 28-day treatment cycle, adverse event surveillance, liver function enzyme levels, WBC with differential, ANC, aPTT, and PT are measured. This is repeated for each 28 day treatment cycle until disease progression or end of treatment. A final assessment is performed 30 days post-final necuparanib dose.
Interventions
- DRUG placebo
- DRUG nab-paclitaxel
- DRUG gemcitabine
- DRUG Necuparanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-10-24 |
| Phase | Phase 1 |
Why NCT01621243 stopped before completion
NCT01621243 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT01621243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621243 about?
NCT01621243 is a clinical study titled "M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer". People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies ...
What is the current status of trial NCT01621243?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2012-05. Estimated completion is 2016-10-24.
What interventions are being tested in trial NCT01621243?
The interventions under investigation include: placebo (DRUG), nab-paclitaxel (DRUG), gemcitabine (DRUG), Necuparanib (DRUG).
Who is sponsoring clinical trial NCT01621243?
This trial is sponsored by Momenta Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01621243's enrollment target sits among peer trials
128 452nd of 2000 higher than 1,542 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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