Drug Interaction Study of SAR302503 in Patients With Solid Tumor

NCT01585623 | Completed Phase 1

• 2 other identifiers: INT12497U1111-1125-8930
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast

  predose and up to 24 hours post dose on Days -1, 1, 15 and 16

Secondary Outcomes (4)

• 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)

Study Arms (2)

Segment 1

EXPERIMENTAL

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

Drug: SAR302503; Drug: omeprazol; Drug: metoprolol; Drug: midazolam

Segment 2

EXPERIMENTAL

SAR302503 500 mg once daily without food in 28-day per cycle

Drug: SAR302503

Interventions

SAR302503 DRUG

Pharmaceutical form:capsule Route of administration: oral

Segment 1; Segment 2

omeprazol DRUG

Pharmaceutical form:capsule Route of administration: oral

Segment 1

metoprolol DRUG

Pharmaceutical form:tablet Route of administration: oral

Segment 1

midazolam DRUG

Pharmaceutical form:solution Route of administration: oral

Segment 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Investigational Site Number 840004

Augusta, Georgia, 30912, United States

Location

Investigational Site Number 840001

Detroit, Michigan, 48201, United States

Location

Investigational Site Number 840002

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

fedratinib; Omeprazole; Metoprolol; Midazolam

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Benzodiazepines; Benzazepines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 26, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 5, 2025

Record last verified: 2013-03

Locations

US (3)