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NCT01430572 · ClinicalTrials.gov registry record · Phase 1

Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients

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

Completed
Registry status
Phase 1
Development phase
62
Enrollment target

NCT01430572: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT01430572 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01430572, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels. Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.

Primary Outcome

MTD defined as highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) was less than 33%, with no more than 1 of 6 evaluable participants had a DLT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Interventions

  • DRUG Everolimus
  • DRUG Pazopanib

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2011-10-07
Est. Completion 2020-05-12
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01430572 record still lists

NCT01430572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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

NCT01430572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01430572 about?

NCT01430572 is a clinical study titled "Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients". The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Pazopanib is designed to block different receptors ...

What is the current status of trial NCT01430572?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2011-10-07. Estimated completion is 2020-05-12.

What interventions are being tested in trial NCT01430572?

The interventions under investigation include: Everolimus (DRUG), Pazopanib (DRUG).

Who is sponsoring clinical trial NCT01430572?

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 NCT01430572's enrollment target sits among peer trials

62 824th of 2000 higher than 1,173 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 NCT01430572, the US trial registry maintained by the National Library of Medicine. NCT01430572 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.