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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.
 
ClinicalTrials.gov Identifier: NCT01358331
Recruitment Status : Terminated
First Posted : May 23, 2011
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Tumor, Solid Drug: MK-8353 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (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))
Actual Study Start Date : November 4, 2011
Actual Primary Completion Date : May 20, 2014
Actual Study Completion Date : May 20, 2014

Arm Intervention/treatment
Experimental: MK-8353 100 mg twice daily (BID)
100 mg capsules administered orally twice daily for 28 days for each cycle
Drug: MK-8353
Administered orally twice daily for 28 days for each cycle

Experimental: MK-8353 200 mg BID
200 mg capsules administered orally twice daily for 28 days for each cycle
Drug: MK-8353
Administered orally twice daily for 28 days for each cycle

Experimental: MK-6353 300 mg BID
300 mg capsules administered orally twice daily for 28 days for each cycle
Drug: MK-8353
Administered orally twice daily for 28 days for each cycle

Experimental: MK-8353 350 mg BID
350 mg capsules administered orally twice daily for 28 days for each cycle
Drug: MK-8353
Administered orally twice daily for 28 days for each cycle

Experimental: MK-8353 400 mg BID
400 mg capsules administered orally twice daily for 28 days for each cycle
Drug: MK-8353
Administered orally twice daily for 28 days for each cycle

Experimental: MK-8353 800 mg BID
800 mg capsules administered orally twice daily for 28 days for each cycle
Drug: MK-8353
Administered orally twice daily for 28 days for each cycle




Primary Outcome Measures :
  1. Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycles of 28 days, up to approximately 9 months treatment and a 30-day follow-up period for a total time of up to approximately 10 months ]
    DLT was derived from the toxicities observed during the first cycle (28 days) for each dose level. DLT is defined as any hematologic or non-hematologic toxicity ≥Grade 3 as pre-specified per protocol, or drug-related toxicity, regardless of Common Terminology Criteria for Adverse Events (CTCAE) grade that causes >20% of the intended total number of doses in Cycle 1 to be missed.

  2. Number of Participants With Overall Response Rate [ Time Frame: Baseline, and every 8 weeks until disease progression or discontinuation from study up to approximately 10 months ]
    Overall Response rate is defined as the number of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 males 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358331


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck, Sharpe & Dohme Corp.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01358331    
Other Study ID Numbers: P06203
2012-002696-33 ( EudraCT Number )
MK-8353-001 ( Other Identifier: Merck )
First Posted: May 23, 2011    Key Record Dates
Results First Posted: April 2, 2020
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php