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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))

Phase 1
18 Years
Open (Enrolling)
Tumor, Solid

Thank you

Trial Information

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))

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose-limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 of Part 1 only (approximately 28 days)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

June 2015

Related Keywords:

  • Tumor, Solid



Call for Information (Investigational Site 0012) Houston, Texas  77030
Call for Information (Investigational Site 0015) Berkeley, California  94704
Call for Information (Investigational Site 0003) Scottsdale, Arizona  85258
Call for Information (Investigational Site 0004) Boston, Massachusetts  
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Call for Information (Investigational Site 0013) Pittsburgh, Pennsylvania  15232
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