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NCT01582009 · ClinicalTrials.gov registry record · Phase 1

Panobinostat and Everolimus in Treating Patients With Metastatic or Unresectable Renal Cell Cancer That Does Not Respond to Treatment With Sunitinib Malate or Sorafenib Tosylate

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
26
Enrollment target

NCT01582009: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT01582009 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01582009, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

RATIONALE: Panobinostat and everolimus 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. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving panobinostat together with everolimus and to see how well they work in treating patients with metastatic or unresectable renal cell cancer that does not respond to treatment with sunitinib malate or sorafenib tosylate

Primary Outcome

6 month PFS survival rate. Calculated as the total number of failures (deaths or progression) divided by the total follow-up or exposure time of patients on study. Assessed using Kaplan Meier and Proportional Hazards.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG panobinostat
  • OTHER pharmacological study
  • DRUG everolimus
  • OTHER liquid chromatography

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-03
Est. Completion 2015-12
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

Why NCT01582009 stopped before completion

NCT01582009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT01582009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01582009 about?

NCT01582009 is a clinical study titled "Panobinostat and Everolimus in Treating Patients With Metastatic or Unresectable Renal Cell Cancer That Does Not Respond to Treatment With Sunitinib Malate or Sorafenib Tosylate". RATIONALE: Panobinostat and everolimus 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. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving panobinostat together with everolimus and to s...

What is the current status of trial NCT01582009?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-03. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01582009?

The interventions under investigation include: laboratory biomarker analysis (OTHER), panobinostat (DRUG), pharmacological study (OTHER), everolimus (DRUG), liquid chromatography (OTHER).

Who is sponsoring clinical trial NCT01582009?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01582009's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01582009, the US trial registry maintained by the National Library of Medicine. NCT01582009 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.