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Completed

NCT Number: NCT00694083

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

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

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Key information

Conditions

Neoplasm Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ridaforolimus

Drug

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

Primary outcomes

  1. Number of Participants With Ridaforolimus Dose Limiting Toxicities

    Time frame: Cycle 1 (28 days)

Secondary outcomes

  1. Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg)

    Time frame: Day 1

  2. Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg)

    Time frame: Day 26

  3. Maximum Plasma Concentration (Cmax) for Day 1 (Single Dose of Ridaforolimus, 20 mg or 40 mg)

    Time frame: Day 1

  4. Maximum Plasma Concentration (Cmax) for Day 26 (Multiple Doses of Ridaforolimus, 20 mg and 40 mg)

    Time frame: Day 26

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 10, 2008
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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