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NCT01266057 · ClinicalTrials.gov registry record · Phase 1

Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer

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

Completed
Registry status
Phase 1
Development phase
143
Enrollment target
1
Study location

NCT01266057: Completed Phase 1 study of Advanced Cancers, sponsored by M.D. Anderson Cancer Center.

NCT01266057 is a Phase 1 study of Advanced Cancers that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 143 participants, above the 56-participant average among 10 other Advanced Cancers trials with a reported enrollment target (155% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01266057, a Phase 1 study of Advanced Cancers, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
143 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of sirolimus or vorinostat that can be given in combination with hydroxychloroquine to patients with advanced cancer. The safety of these drug combinations will also be studied.

Primary Outcome

Maximum tolerated dose (MTD) defined defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in the first treatment cycle. Dose limiting toxicity (DLT) defined as: Any grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v3.0 that is possibly, probably or definitely related to any of the three study medications, even if expected. This is to include symptoms/signs of vascular leak or cytokine release syndrome; or any sever

Conditions Studied

Interventions

  • DRUG Sirolimus
  • DRUG Vorinostat
  • DRUG Hydroxychloroquine

Study Locations (1)

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2011-04-28
Est. Completion 2021-02-11
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01266057 record still lists

NCT01266057 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, above the 56-participant average among 10 other Advanced Cancers trials with a reported enrollment target (155% higher).

The record links to 1 condition, with Advanced Cancers appearing as the primary indexed condition, and to 3 interventions - of which Sirolimus is the first listed.

NCT01266057 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01266057 about?

NCT01266057 is a clinical study titled "Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer". The goal of this clinical research study is to find the highest tolerable dose of sirolimus or vorinostat that can be given in combination with hydroxychloroquine to patients with advanced cancer. The safety of these drug combinations will also be studied.

What is the current status of trial NCT01266057?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2011-04-28. Estimated completion is 2021-02-11.

What conditions does trial NCT01266057 study?

This clinical trial studies the following conditions: Advanced Cancers.

What interventions are being tested in trial NCT01266057?

The interventions under investigation include: Sirolimus (DRUG), Vorinostat (DRUG), Hydroxychloroquine (DRUG).

Who is sponsoring clinical trial NCT01266057?

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

Where is trial NCT01266057 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Cancers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01266057's enrollment target sits among peer trials

143 2nd of 10 the highest of 10 other Advanced Cancers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Cancers 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 NCT01266057, the US trial registry maintained by the National Library of Medicine. NCT01266057 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.