A Study of the Safety, Tolerability, and Efficacy of MK-8353 (Formerly SCH 900353) in Participants With Advanced Solid Tumors (MK-8353-001 (Formerly P06203) AM3)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01358331
First received: May 19, 2011
Last updated: April 2, 2013
Last verified: April 2013
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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:
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: | 117 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | April 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 | |
| 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 | |
| New Zealand | |
| Merck Sharp & Dohme (New Zealand) Ltd., | Recruiting |
| Wellington, New Zealand | |
| Contact: Gary Jankelowitz 61 2 8988 8246 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01358331 History of Changes |
| Other Study ID Numbers: | P06203, 2012-002696-33 |
| Study First Received: | May 19, 2011 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 16, 2013