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NCT01122615 · ClinicalTrials.gov registry record · Phase 1

Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target

NCT01122615: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT01122615 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01122615, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of sunitinib and temsirolimus that can be given to patients with metastatic kidney cancer.

Primary Outcome

Determination of MTD based on the occurrence of dose limiting toxicities (DLTs) during cycle one only after administration of study drugs on day one through day 21. All toxicity graded according to criteria of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.0.

Interventions

  • DRUG Sunitinib
  • DRUG Temsirolimus

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-05
Est. Completion 2014-07
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01122615 record still lists

NCT01122615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Sunitinib is the first listed.

NCT01122615 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01122615 about?

NCT01122615 is a clinical study titled "Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)". The goal of this clinical research study is to find the highest tolerable dose of the combination of sunitinib and temsirolimus that can be given to patients with metastatic kidney cancer.

What is the current status of trial NCT01122615?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-05. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01122615?

The interventions under investigation include: Sunitinib (DRUG), Temsirolimus (DRUG).

Who is sponsoring clinical trial NCT01122615?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01122615's enrollment target sits among peer trials

23 1596th of 2000 higher than 400 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 NCT01122615, the US trial registry maintained by the National Library of Medicine. NCT01122615 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.