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Phase 1 Safety Testing of SAR405838

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01636479
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 2, 2012
First Posted Date  ICMJE July 10, 2012
Last Update Posted Date May 17, 2018
Study Start Date  ICMJE July 13, 2012
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ]
  • In MTD cohort, clinical benefit [ Time Frame: Until disease progression ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
  • SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) ]
  • In MTD cohort, clinical benefit [ Time Frame: Until disease progression (about 2 years) ]
Change History Complete list of historical versions of study NCT01636479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2013)
  • Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ]
  • PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ]
  • Biomarkers [ Time Frame: Baseline to end of study ]
  • Clinical response [ Time Frame: Baseline to end of study ]
  • Drug administration compliance [ Time Frame: Baseline to end of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
  • Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study (about 2 years) ]
  • PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study (about 2 years) ]
  • Biomarkers [ Time Frame: Baseline to end of study (about 2 years) ]
  • Clinical response [ Time Frame: Baseline to end of study (about 2 years) ]
  • Drug administration compliance [ Time Frame: Baseline to end of study (about 2 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Safety Testing of SAR405838
Official Title  ICMJE A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
Brief Summary

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.
Detailed Description Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm Malignant
Intervention  ICMJE Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral
Study Arms  ICMJE Experimental: SAR405838
SAR405838 in escalating doses
Intervention: Drug: SAR405838
Publications * de Jonge M, de Weger VA, Dickson MA, Langenberg M, Le Cesne A, Wagner AJ, Hsu K, Zheng W, Macé S, Tuffal G, Thomas K, Schellens JH. A phase I study of SAR405838, a novel human double minute 2 (HDM2) antagonist, in patients with solid tumours. Eur J Cancer. 2017 May;76:144-151. doi: 10.1016/j.ejca.2017.02.005. Epub 2017 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
77
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2012)
58
Actual Study Completion Date  ICMJE March 5, 2018
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01636479
Other Study ID Numbers  ICMJE TED12318
2012-000733-39
U1111-1127-2911 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2018

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