A Study to Evaluate the Effect of MK-8669 (Ridaforolimus) on QTc Interval in Participants With Advanced Cancer (MK-8669-037 AM1)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00874731
First received: March 31, 2009
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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 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 participants will receive ridaforolimus at the current therapeutic dose (40 mg x 5 days).
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic or Locally Advanced Cancer. |
Drug: Ridaforolimus 100 mg Drug: Ridaforolimus 40 mg Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Clinical Trial to Assess the Effect of Deforolimus (AP23573; MK-8669) on QTc Interval in Patients (Protocol 037) |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Mean change from Baseline to 0.5 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 0.5 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 1 hour in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 1 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 2 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 2 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 3 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 3 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 4 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 4 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 6 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 6 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 8 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 8 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 10 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 10 ] [ Designated as safety issue: No ]
- Mean change from Baseline to 24 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo [ Time Frame: Baseline and Hour 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants experiencing adverse events [ Time Frame: In Part 1, Day 1 for placebo and Day 2 for ridaforolimus 100 mg; Part 2, from Day 1 up to 30 days after the last ridaforolimus 40 mg dose (up to approximately 1 year). ] [ Designated as safety issue: Yes ]
- Number of Participants who Discontinued From Study Drug due to Adverse Events [ Time Frame: In Part 1, Day 1 for placebo and Day 2 for ridaforolimus 100 mg; Part 2, from Day 1 up to the last ridaforolimus 40 mg dose (up to approximately 1 year). ] [ Designated as safety issue: Yes ]
| Enrollment: | 23 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ridaforolimus
Part 1: Participants receive a single oral dose of placebo (10 tablets) on Day 1 and a single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) on Day 2. Each dose to be followed by 24 hours of Holter electrocardiogram (ECG) monitoring for QTc assessment. Part 2 (optional): Participants receive a weekly regimen of daily oral doses of 40 mg ridaforolimus (4 x 10 mg tablets) for 5 consecutive days followed by 2 days off-drug. |
Drug: Ridaforolimus 100 mg
Part 1: A single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) was given on Day 2.
Other Names:
Drug: Ridaforolimus 40 mg
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.
Other Names:
Drug: Placebo
A single oral dose of placebo (10 x placebo tablets) was given on Day 1.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists
- If the patient is a female, she must be postmenopausal or if she is of childbearing potential she must have blood pregnancy tests during the study and be willing to use 2 methods of contraception
- If the patient is male and has female partners of child-bearing potential, he must agree to use a medically acceptable method of contraception during the study and for 30 days after the last dose of study drug
Exclusion Criteria:
- Patient has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks
- Patient is currently receiving other anti-cancer therapy
- Patient is currently participating or has participated in a study with an investigation drug or device within the last 30 days
- Patient has a primary central nervous system tumor or active brain metastases
- Patient has a psychiatric disorder
- Patient uses illegal drugs
- Patient is pregnant or breastfeeding
- Patient is known to be human immunodeficiency virus (HIV) positive
- Patient has a known history of Hepatitis B or C
- Patient has newly diagnosed diabetes
- Patient has an active infection
- Patient is unable to swallow capsules
- Patient has received a blood transfusion with one week of study entry
- Patient has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrythmia
- Patient has a known sensitivity to the components of the study drug
- Patient has not adequately recovered from any prior surgical procedure
- Patient does not agree to refrain from use of herbal remedies and consumption of grapefruit juice for 2 weeks prior to and during the study
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00874731 History of Changes |
| Other Study ID Numbers: | MK-8669-037, 2009_569 |
| Study First Received: | March 31, 2009 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Sirolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013