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NCT01510119 · ClinicalTrials.gov registry record · Phase 1
Autophagy Inhibition to Augment Mammilian Target of Rapamycin (mTOR) Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine (HCQ) in Patients With Previously Treated Renal Cell Carcinoma
A Phase 1 study of Metastatic Clear Cell Renal Cell Carcinoma, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT01510119: Completed Phase 1 study of Metastatic Clear Cell Renal Cell Carcinoma, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01510119 is a Phase 1 study of Metastatic Clear Cell Renal Cell Carcinoma that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 40 participants, below the 150-participant average among 13 other Metastatic Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01510119, a Phase 1 study of Metastatic Clear Cell Renal Cell Carcinoma, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is an open labeled phase I dose escalation study of hydroxychloroquine (HCQ) and RAD001 in patients with advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target population are patients with one to three prior treatments for advanced renal cell carcinoma. In the phase I portion a traditional 3+3 design will be used to determine the maximal tolerated dose and/or recommended phase II dose for HCQ in combination with RAD001 po 10 mg/day.
Conditions Studied
Interventions
- DRUG Hydroxychloroquine
- DRUG RAD001
Study Locations (3)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
- University of Pittsburgh, Hillman Cancer Center - Pittsburgh
New Jersey
- University of Medicine and Dentistry of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-01-05 |
| Phase | Phase 1 |
What the finished NCT01510119 record still lists
NCT01510119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 150-participant average among 13 other Metastatic Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Metastatic Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Hydroxychloroquine is the first listed.
NCT01510119 reports a single indexed study location in Pennsylvania, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01510119 about?
NCT01510119 is a clinical study titled "Autophagy Inhibition to Augment Mammilian Target of Rapamycin (mTOR) Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine (HCQ) in Patients With Previously Treated Renal Cell Carcinoma". This is an open labeled phase I dose escalation study of hydroxychloroquine (HCQ) and RAD001 in patients with advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target population are patients with one to three prior treatments for advanced renal cell carcinoma. In the...
What is the current status of trial NCT01510119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2011-09. Estimated completion is 2017-01-05.
What conditions does trial NCT01510119 study?
This clinical trial studies the following conditions: Metastatic Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT01510119?
The interventions under investigation include: Hydroxychloroquine (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT01510119?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01510119 being conducted?
This trial has 3 study locations across New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01510119's enrollment target sits among peer trials
40 10th of 13 higher than 4 of 13 other Metastatic Clear Cell Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Clear Cell Renal Cell Carcinoma 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.
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