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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358331
Recruitment Status : Terminated
First Posted : May 23, 2011
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

May 19, 2011
May 23, 2011
June 8, 2015
November 2011
May 2014   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01358331 on Archive Site
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A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001)
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))
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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tumor, Solid
Drug: MK-8353
Other Name: SCH 900353
Experimental: MK-8353
capsules, orally administered every day in 28-day cycles
Intervention: Drug: MK-8353
Moschos SJ, Sullivan RJ, Hwu WJ, Ramanathan RK, Adjei AA, Fong PC, Shapira-Frommer R, Tawbi HA, Rubino J, Rush TS 3rd, Zhang D, Miselis NR, Samatar AA, Chun P, Rubin EH, Schiller J, Long BJ, Dayananth P, Carr D, Kirschmeier P, Bishop WR, Deng Y, Cooper A, Shipps GW, Moreno BH, Robert L, Ribas A, Flaherty KT. Development of MK-8353, an orally administered ERK1/2 inhibitor, in patients with advanced solid tumors. JCI Insight. 2018 Feb 22;3(4). pii: 92352. doi: 10.1172/jci.insight.92352. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
May 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Israel,   New Zealand,   United States
2012-002696-33 ( EudraCT Number )
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
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Merck Sharp & Dohme Corp.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP