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NCT01532687 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT01532687: Completed Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT01532687 is a Phase 2 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532687, a Phase 2 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well gemcitabine hydrochloride works with or without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma. 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. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride is more effective with or without pazopanib hydrochloride in treating patients with soft tissue sarcoma.
Primary Outcome
Compared using a one-sided Gehan-Wilcoxon test stratified by sarcoma subtype. Kaplan-Meier estimates for each treatment arm will be presented with the estimated hazard ratios and their associated confidence intervals. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5 mm (target lesions), or m
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Gemcitabine
- DRUG Gemcitabine Hydrochloride
- DRUG Pazopanib
- DRUG Pazopanib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-03-13 |
| Est. Completion | 2019-10-31 |
| Phase | Phase 2 |
What the finished NCT01532687 record still lists
NCT01532687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01532687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532687 about?
NCT01532687 is a clinical study titled "Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma". This randomized phase II trial studies how well gemcitabine hydrochloride works with or without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, e...
What is the current status of trial NCT01532687?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2012-03-13. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT01532687?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Gemcitabine (DRUG), Gemcitabine Hydrochloride (DRUG), Pazopanib (DRUG), Pazopanib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01532687?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532687's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 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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