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Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumor

Intervention: SAR302503 (Drug); omeprazol (Drug); metoprolol (Drug); midazolam (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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

Clinical Details

Official title: An Open-label, Two-treatment Crossover Pharmacokinetic Interaction Study of Repeated Doses of SAR302503 on Pharmacokinetics of a Single Dose Cocktail of Omeprazole, Metoprolol, and Midazolam Used as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 Activities, Respectively in Adult Patients With Refractory Solid Tumors

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast

Secondary outcome:

Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter : Cmax, Tmax, and t1/2z

SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24

Clinical and laboratory events graded by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 (Segment 1 and 2)

Objective response ratio (Complete response (CR) and partial response (PR)) (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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria :

- Histologically or cytologically confirmed advanced solid malignancy that is

metastatic or unresectable, and for which standard curative measures do not exist

- Signed informed consent

Exclusion criteria:

- 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.

Locations and Contacts

Investigational Site Number 840004, Augusta, Georgia 30912, United States

Investigational Site Number 840001, Detroit, Michigan 48201, United States

Investigational Site Number 840002, Philadelphia, Pennsylvania 19111, United States

Additional Information

Starting date: June 2012
Last updated: March 21, 2013

Page last updated: August 23, 2015

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