Trial record 1 of 1 for:    INT12497
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Drug Interaction Study of SAR302503 in Patients With Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01585623
First received: April 13, 2012
Last updated: March 21, 2013
Last verified: March 2013

April 13, 2012
March 21, 2013
June 2012
March 2013   (final data collection date for primary outcome measure)
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast [ Time Frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01585623 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24 [ Time Frame: Day-1 to Day 16 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2) [ Time Frame: up to 2 cycles ( i.e. 10 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Drug Interaction Study of SAR302503 in Patients With Solid Tumor
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

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor
  • Drug: SAR302503

    Pharmaceutical form:capsule

    Route of administration: oral

  • Drug: omeprazol

    Pharmaceutical form:capsule

    Route of administration: oral

  • Drug: metoprolol

    Pharmaceutical form:tablet

    Route of administration: oral

  • Drug: midazolam

    Pharmaceutical form:solution

    Route of administration: oral

  • Experimental: Segment 1
    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
    Interventions:
    • Drug: SAR302503
    • Drug: omeprazol
    • Drug: metoprolol
    • Drug: midazolam
  • Experimental: Segment 2
    SAR302503 500 mg once daily without food in 28-day per cycle
    Intervention: Drug: SAR302503
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2013
March 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01585623
INT12497, U1111-1125-8930
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP