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Phase 1 Safety Testing of SAR405838

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01636479
Collaborator
(none)
77
Enrollment
7
Locations
1
Arm
67.7
Duration (Months)
11
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jul 13, 2012
Actual Primary Completion Date :
Mar 5, 2018
Actual Study Completion Date :
Mar 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAR405838

SAR405838 in escalating doses

Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral

Outcome Measures

Primary Outcome Measures

  1. SAR405838 Maximum tolerated dose (MTD) [Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule]

  2. In MTD cohort, clinical benefit [Until disease progression]

Secondary Outcome Measures

  1. Adverse events (eg, number of patients experiencing AEs) [Baseline to end of study]

  2. PK parameters (Cmax, Tmax, AUC) [Baseline to end of study]

  3. Biomarkers [Baseline to end of study]

  4. Clinical response [Baseline to end of study]

  5. Drug administration compliance [Baseline to end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Investigational Site Number 840101 Boston Massachusetts United States 02114
2 Investigational Site Number 840001 Boston Massachusetts United States 02115
3 Investigational Site Number 840002 New York New York United States 10021
4 Investigational Site Number 250001 Villejuif France 94805
5 Investigational Site Number 528001 Amsterdam Netherlands 1066 CX
6 Investigational Site Number 528003 Rotterdam Netherlands 3075 EA
7 Investigational Site Number 528002 Utrecht Netherlands 3584 CX

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT01636479
Other Study ID Numbers:
  • TED12318
  • 2012-000733-39
  • U1111-1127-2911
First Posted:
Jul 10, 2012
Last Update Posted:
May 17, 2018
Last Verified:
May 1, 2018
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of May 17, 2018