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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: SAR405838 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 13, 2012
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: SAR405838
SAR405838 in escalating doses
 Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral


Outcome Measures
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Primary Outcome Measures :
  1. SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ]
  2. In MTD cohort, clinical benefit [ Time Frame: Until disease progression ]

Secondary Outcome Measures :
  1. Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ]
  2. PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ]
  3. Biomarkers [ Time Frame: Baseline to end of study ]
  4. Clinical response [ Time Frame: Baseline to end of study ]
  5. Drug administration compliance [ Time Frame: Baseline to end of study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636479


Locations
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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
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01636479    
Other Study ID Numbers: TED12318
2012-000733-39
U1111-1127-2911 ( Other Identifier: UTN )
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Neoplasms