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

Tumor, Solid Clinical Trial

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))

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01358331
• Other study ID #: P06203
• Secondary ID: 2012-002696-33MK
• Status: Terminated
• Phase: Phase 1
• Start date: November 4, 2011
• Est. completion date: May 20, 2014

Study information

• Verified date: March 2020
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 20, 2014
• Est. primary completion date: May 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Drug:
• MK-8353
Administered orally twice daily for 28 days for each cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose-Limiting Toxicities (DLTs)	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.	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
Primary	Number of Participants With Overall Response Rate	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.	Baseline, and every 8 weeks until disease progression or discontinuation from study up to approximately 10 months