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NCT01461915 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01461915: Clinical Trial Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT01461915 is a Phase 2 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461915, a Phase 2 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This randomized, Phase 2, open label study aims to assess the efficacy and safety of gemcitabine + nab paclitaxel with or without dociparstat (ODSH) as first line treatment of metastatic pancreatic cancer. This study consists of 2 periods: a Run-in Period and a Randomized Period.
Primary Outcome
The primary objective of this study is to evaluate progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines Version 1.1. This will be assessed from Baseline to disease progression or death (whichever occurred first), for up to 9 months.
Interventions
- DRUG Gemcitabine
- DRUG Nab paclitaxel
- DRUG Dociparstat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
Why NCT01461915 stopped before completion
NCT01461915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT01461915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01461915 about?
NCT01461915 is a clinical study titled "Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients". This randomized, Phase 2, open label study aims to assess the efficacy and safety of gemcitabine + nab paclitaxel with or without dociparstat (ODSH) as first line treatment of metastatic pancreatic cancer. This study consists of 2 periods: a Run-in Period and a Randomized Period.
What is the current status of trial NCT01461915?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2011-11. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01461915?
The interventions under investigation include: Gemcitabine (DRUG), Nab paclitaxel (DRUG), Dociparstat (DRUG).
Who is sponsoring clinical trial NCT01461915?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01461915's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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