At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 23 enrolled

Drug / intervention

Ridaforolimus 100 mg +2 moredrug

Likely dose

Ridaforolimus 100 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00874731

NCT00874731Phase 1Completed

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A Clinical Trial to Assess the Effect of Ridaforolimus (AP23573; MK-8669) on QTc Interval in Patients

Merck Sharp & Dohme LLC·interventional·Posted Apr 2, 2009·Updated May 6, 2019

In Brief

A Phase 1 clinical trial evaluating Ridaforolimus 100 mg, Ridaforolimus 40 mg, and 1 other intervention for Metastatic or Locally Advanced Cancer. Completed, enrolled 23 participants.

Detailed Summary

To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the electrical activity of the heart) in participants with advanced cancer. This study will be done in 2 parts. Part 1 (Pt 1) will evaluate the effect of a single 100 mg dose of ridaforolimus on QT interval in participants with advanced cancer. Fridericias's correction (QTcF) will be used. In Part 2 (Pt 2), participants will receive ridaforolimus at the current therapeutic dose (40 mg x 5 days).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMetastatic or Locally Advanced Cancer

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

First PostedApr 2009

Enrollment StartApr 2009

Primary CompletionOct 2009

Study CompletionApr 2010

TodayJul 2026

First PostedApr 2, 2009

Enrollment StartApr 28, 2009

Primary CompletionOct 30, 2009

Study CompletionApr 30, 2010

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 17.3 years ago

Interventions

Ridaforolimus 100 mgdrug

Part 1: A single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) was given on Day 2.

Ridaforolimus 40 mgdrug

Part 2 (optional): Ridaforolimus 40 mg (4 x 10 mg tablets) was received on a regimen of daily oral doses for 5 consecutive days followed by 2 days off-drug.

Placebodrug

Part 1: A single oral dose of placebo (10 x placebo tablets) was given on Day 1.