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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00694083
First received: May 29, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Neoplasm
Drug: Ridaforolimus
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MK-8669 in Patients With Metastatic or Locally Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Ridaforolimus Dose Limiting Toxicities [ Time Frame: Cycle 1 (28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg) [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) for Day 1 (Single Dose of Ridaforolimus, 20 mg or 40 mg) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) for Day 26 (Multiple Doses of Ridaforolimus, 20 mg and 40 mg) [ Time Frame: Day 26 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MK-8669

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694083

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00694083     History of Changes
Other Study ID Numbers: 8669-003, 2008_011
Study First Received: May 29, 2008
Last Updated: March 13, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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 July 24, 2014