Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

Primary Objective: * To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). * To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: * To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 * To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 * To determine antitumor activity in Segment 2

Key facts

Study ID: NCT01585623
Run by: Bristol-Myers Squibb
People needed: 16
Starts: 2012-06-01
Expected to finish: 2013-03-01
Last updated by the study team: 2025-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist
Signed informed consent

You may not qualify if…

Less than 18 years of age.
Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
Inability to follow study requirements and schedule
Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy
Serious medical illness at same time of study and/or significantly abnormal lab reports
Lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
Continued toxic effects of prior chemotherapy
Evidence of other concurrent active malignancy
Other concurrent serious illness or medical condition
Cardiac abnormalities include bradycardia, AV block or other conduction defect on ECG, and patients taking a beta blocker.
Patients with Insulin-Dependent Diabetes Mellitus.
Patients with known active (acute or chronic) hepatitis A, B, C, and hepatitis B and C carries. Prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]).
Inadequate organ function
History of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

Investigational Site Number 840004 — Augusta, Georgia, United States
Investigational Site Number 840001 — Detroit, Michigan, United States
Investigational Site Number 840002 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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