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Phase 1 Safety Testing of SAR405838

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01636479
First received: July 2, 2012
Last updated: August 25, 2016
Last verified: August 2016
History of Changes
  Purpose

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.

Condition Intervention Phase
Neoplasm Malignant
 Drug: SAR405838
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 82
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR405838
SAR405838 in escalating doses
 Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636479

Locations
United States, Massachusetts
Investigational Site Number 840101
Boston, Massachusetts, United States, 02114
Investigational Site Number 840001
Boston, Massachusetts, United States, 02115
United States, New York
Investigational Site Number 840002
New York, New York, United States, 10021
France
Investigational Site Number 250001
Villejuif, France, 94805
Netherlands
Investigational Site Number 528001
Amsterdam, Netherlands, 1066 CX
Investigational Site Number 528003
Rotterdam, Netherlands, 3075 EA
Investigational Site Number 528002
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01636479     History of Changes
Other Study ID Numbers: TED12318  2012-000733-39  U1111-1127-2911 
Study First Received: July 2, 2012
Last Updated: August 25, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2016