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A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001)

This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 19, 2011
Last updated: June 5, 2015
Last verified: June 2015
This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given as single agent oral therapy for participants with advanced solid tumors will be done into two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2 dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to see if MK-8353 is effective as single agent therapy.

Condition Intervention Phase
Tumor, Solid
Drug: MK-8353
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability and Efficacy of MK-8353 (Formerly SCH 900353) in Subjects With Advanced Solid Tumors (Protocol No. 001 (Formerly P06203))

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

Primary Outcome Measures:
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1 of Part 1 only (approximately 28 days) ]
  • Number of participants with complete response (CR) or partial response (PR) [ Time Frame: Baseline, and every 8 weeks until disease progression or discontinuation from study ]

Enrollment: 26
Study Start Date: November 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8353
capsules, orally administered every day in 28-day cycles
Drug: MK-8353
Other Name: SCH 900353


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically/histologically confirmed solid tumor (metastatic or locally advanced disease) that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
  • Participants of childbearing potential must have negative pregnancy test; females and male must agree to use effective contraception during the course of the trial and for 90 days after stopping study drug.
  • For Part 1b and Part 2, participant with metastatic melanoma or metastatic colorectal cancer with at least one measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of ≥3 months.
  • Adequate organ function.

Exclusion Criteria:

  • Unstable or progressing central nervous system (CNS) metastasis unless asymptomatic for 3 months, with no need for steroids or antiseizure medications.
  • Active gastrointestinal disease or a disorder or a history of surgery that significantly alters gastrointestinal motility or absorption.
  • Has not recovered from previous therapy and had any chemotherapy, biologic, or hormonal therapy within 4 weeks of study enrollment.
  • Radiation therapy (except palliative radiation to bone lesions) within 4 weeks of study enrollment.
  • More than 3 prior regimens of chemotherapy, biologic therapy, hormonal therapy, or investigational drugs not including adjuvant or neoadjuvant treatments.
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic diseases.
  • Mean QTcF interval (interval on the electrocardiogram corrected for heart rate using Fridericia's correction) > 450 msec at baseline.
  • Known Human Immunodeficiency Virus (HIV) infection, hepatitis infection, or tuberculosis infection.
  • Current participation in any other interventional clinical study.
  • History of significant eye disease, including glaucoma, retinopathy, or retinal vein occlusion.
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01358331     History of Changes
Other Study ID Numbers: P06203
2012-002696-33 ( EudraCT Number )
Study First Received: May 19, 2011
Last Updated: June 5, 2015 processed this record on April 28, 2017