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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Neoplasm

Treatments: Drug: Ridaforolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694083

2008_011 (Other Identifier)

8669-003

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Ridaforolimus

Experimental group

Description:

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).

Treatment:

Drug: Ridaforolimus