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Completed

NCT Number: NCT01585623

Drug Interaction Study of SAR302503 in Patients With Solid Tumor

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

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 840004, Augusta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR302503

Drug

Pharmaceutical form:capsule

Route of administration: oral

omeprazol

Drug

Pharmaceutical form:capsule

Route of administration: oral

metoprolol

Drug

Pharmaceutical form:tablet

Route of administration: oral

midazolam

Drug

Pharmaceutical form:solution

Route of administration: oral

Primary outcomes

  1. Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast

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

Secondary outcomes

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

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

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

    Time frame: Day-1 to Day 16

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

    Time frame: up to maximum 2 years

  4. Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2)

    Time frame: up to 2 cycles ( i.e. 10 weeks)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2012
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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