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

Phase 1

Completed

• Conditions: Neoplasm
• Interventions: Drug: Ridaforolimus

• Registration Number: NCT00694083
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-09
• Study Start: 2008-06-10
• Study First Posted: 2008-06-10
• Primary Completion: 2009-09-06
• Study Completion: 2009-09-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ridaforolimus	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Ridaforolimus Dose Limiting Toxicities	Cycle 1 (28 days)

Secondary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg)	Day 1
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
Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg)	Day 26