Phase 1 Safety Testing of SAR405838

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01636479
First received: July 2, 2012
Last updated: July 17, 2014
Last verified: July 2014

July 2, 2012
July 17, 2014
July 2012
March 2015   (final data collection date for primary outcome measure)
  • SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ] [ Designated as safety issue: No ]
  • In MTD cohort, clinical benefit [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
  • SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) ] [ Designated as safety issue: Yes ]
  • In MTD cohort, clinical benefit [ Time Frame: Until disease progression (about 2 years) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01636479 on ClinicalTrials.gov Archive Site
  • Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
  • PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
  • Drug administration compliance [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
  • Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study (about 2 years) ] [ Designated as safety issue: Yes ]
  • PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study (about 2 years) ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Baseline to end of study (about 2 years) ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: Baseline to end of study (about 2 years) ] [ Designated as safety issue: No ]
  • Drug administration compliance [ Time Frame: Baseline to end of study (about 2 years) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 1 Safety Testing of SAR405838
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer

Primary Objectives:

  • To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).
  • To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.

Secondary Objectives:

  • Pharmacokinetic (PK) profile of SAR405838.
  • Biomarkers in association with SAR405838.
  • Anti-tumor activity in response to SAR405838.
  • Food effect on SAR405838 PK.
  • Compliance with SAR405838 treatment.
  • Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm Malignant
Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral
Experimental: SAR405838
SAR405838 in escalating doses
Intervention: Drug: SAR405838
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
82
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled.
  • For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included.
  • Presence of locally advanced or metastatic disease with at least one measurable lesion.

Exclusion criteria:

  • Age <18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of >1.
  • Life expectancy <12 weeks.
  • Unstable brain or leptomeningeal disease based on history and physical examination.
  • Inadequate organ functions, positive pregnancy test.
  • Pregnancy or breast-feeding.
  • Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment.
  • Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
  • Recent (3 months) history of acute pancreatitis.

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: For site information, send an email with site number to Contact-Us@sanofi.com
United States,   France,   Netherlands
 
NCT01636479
TED12318, 2012-000733-39, U1111-1127-2911
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2014

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