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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2011-09
Est. Completion 2017-01-05
Phase Phase 1

What the Registry Record Tells You About NCT01510119

The ClinicalTrials.gov registry entry for NCT01510119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 150-participant average among 13 other Metastatic Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (73% lower). The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.