Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: SAR302503; Drug: omeprazol; Drug: metoprolol; Drug: midazolam

• Registration Number: NCT01585623
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

The duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.

Study Timeline

• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-26
• Study Start: 2012-06
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Segment 1	omeprazol	two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days
Segment 1	metoprolol	two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days
Segment 2	SAR302503	SAR302503 500 mg once daily without food in 28-day per cycle
Segment 1	SAR302503	two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days
Segment 1	midazolam	two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days

Primary Outcome Measures

Name	Time	Method
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast	predose and up to 24 hours post dose on Days -1, 1, 15 and 16

Secondary Outcome Measures

Name	Time	Method
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter : Cmax, Tmax, and t1/2z	predose and up to 24 hours post dose on Days -1, 1, 15 and 16
SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24	Day-1 to Day 16
Clinical and laboratory events graded by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 (Segment 1 and 2)	up to maximum 2 years
Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2)	up to 2 cycles ( i.e. 10 weeks)

Trial Locations

Locations (3)

Investigational Site Number 840004; 🇺🇸 Augusta, Georgia, United States

Investigational Site Number 840002; 🇺🇸 Philadelphia, Pennsylvania, United States

Investigational Site Number 840001; 🇺🇸 Detroit, Michigan, United States