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NCT01064622 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT01064622: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01064622 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064622, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
This randomized phase I/II trial studies gemcitabine hydrochloride and vismodegib to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vismodegib may slow the growth of tumor cells. It is not yet known whether giving gemcitabine hydrochloride together with vismodegib is more effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.
Primary Outcome
Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.
Interventions
- DRUG Vismodegib
- DRUG Gemcitabine Hydrochloride
- OTHER Hydrocortisone/Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2009-09-03 |
| Est. Completion | 2013-01-31 |
| Phase | Phase 2 |
What the finished NCT01064622 record still lists
NCT01064622 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Vismodegib is the first listed.
NCT01064622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01064622 about?
NCT01064622 is a clinical study titled "Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer". This randomized phase I/II trial studies gemcitabine hydrochloride and vismodegib to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in differ...
What is the current status of trial NCT01064622?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2009-09-03. Estimated completion is 2013-01-31.
What interventions are being tested in trial NCT01064622?
The interventions under investigation include: Vismodegib (DRUG), Gemcitabine Hydrochloride (DRUG), Hydrocortisone/Placebo (OTHER).
Who is sponsoring clinical trial NCT01064622?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01064622's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 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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