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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



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