Trial record 1 of 1 for:    NCT01358331
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A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001 AM4)

This study is currently recruiting participants.
Verified March 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01358331
First received: May 19, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Safety Study
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))

Resource links provided by NLM:


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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: November 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358331

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Arizona
Call for Information (Investigational Site 0003) Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Call for Information (Investigational Site 0015) Recruiting
Los Angeles, California, United States, 90095
United States, Massachusetts
Call for Information (Investigational Site 0004) Recruiting
Boston, Massachusetts, United States, 02101
United States, New York
Call for Information (Investigational Site 0001) Recruiting
Buffalo, New York, United States, 14263
United States, North Carolina
Call for Information (Investigational Site 0018) Recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Call for Information (Investigational Site 0013) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Call for Information (Investigational Site 0012) Recruiting
Houston, Texas, United States, 77030
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Ofer Sharon    972 9 9539310      
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd., Recruiting
Wellington, New Zealand
Contact: Gary Jankelowitz    61 2 8988 8246      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01358331     History of Changes
Other Study ID Numbers: P06203, 2012-002696-33
Study First Received: May 19, 2011
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014