A Study of the Safety, Tolerability, and Efficacy of SCH 900353 in Participants With Advanced Solid Tumors (P06203 AM2)

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01358331 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-187


This study of the safety, tolerability, and efficacy of 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 SCH 900353 is effective as single agent therapy.


Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Keith Flaherty, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility 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 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.
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