Study of Ridaforolimus (MK-8669) in Participants With Solid Tumors (MK-8669-003)(COMPLETED)

A Phase I Study of MK-8669 in Patients With Metastatic or Locally Advanced Solid Tumors

A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus (MK-8669) in participants with locally advanced or metastatic solid tumors.

Study Overview

• Status: Completed
• Conditions: Neoplasm
• Intervention / Treatment: Drug: Ridaforolimus

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically - Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid Tumors That Have Failed To Respond To Standard Therapy, Or For Which Adequate Standard Therapy Does Not Exist
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Adequate Organ Function

Exclusion Criteria:

• Participant Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks (6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration
• Any central nervous system Metastasis Which Has Symptoms Or Requires Treatment
• Any Primary Central Nervous System Tumor
• Any Symptomatic Ascites Or Plural Effusion Which Requires Treatment
• A History Or Current Evidence Of Any Clinically Significant Disease That Might Confound The Results Of The Study, Complicate The Interpretation Of The Study Results, Interfere With The Participant's Participation, Or Pose An Additional Risk To The Participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ridaforolimus; Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent cycles).	Drug: Ridaforolimus; Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent cycles); Other Names: MK-8669

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Ridaforolimus Dose Limiting Toxicities	Cycle 1 (28 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg)	Day 1
Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg)	Day 26
Maximum Plasma Concentration (Cmax) for Day 1 (Single Dose of Ridaforolimus, 20 mg or 40 mg)	Day 1
Maximum Plasma Concentration (Cmax) for Day 26 (Multiple Doses of Ridaforolimus, 20 mg and 40 mg)	Day 26

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Seki Y, Yamamoto N, Tamura Y, Goto Y, Shibata T, Tanioka M, Asahina H, Nokihara H, Yamada Y, Shimamoto T, Noguchi K, Tamura T. Phase I study for ridaforolimus, an oral mTOR inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Apr;69(4):1099-105. doi: 10.1007/s00280-011-1788-4. Epub 2011 Dec 6.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 29, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 10, 2008

Study Record Updates

• Last Update Posted (Estimate): February 13, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 8669-003; 2008_011 (Other Identifier: Study Number)