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NCT01164228 · ClinicalTrials.gov registry record · Phase 2
Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
A Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT01164228: Completed Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT01164228 is a Phase 2 study that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164228, a Phase 2 study, has completed, sponsored by ECOG-ACRIN Cancer Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study Summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer. PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.
Primary Outcome
Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits).
Interventions
- DRUG Sunitinib
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2010-09-17 |
| Est. Completion | 2021-11-03 |
| Phase | Phase 2 |
What the finished NCT01164228 record still lists
NCT01164228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Sunitinib is the first listed.
NCT01164228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01164228 about?
NCT01164228 is a clinical study titled "Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery". RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the...
What is the current status of trial NCT01164228?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2010-09-17. Estimated completion is 2021-11-03.
What interventions are being tested in trial NCT01164228?
The interventions under investigation include: Sunitinib (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01164228?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01164228's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 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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