Phase 1 Safety Testing of SAR405838

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-13

Study Completion Date

2018-03-05

Brief Summary

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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.

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Detailed Description

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

Conditions

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Neoplasm Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAR405838

SAR405838 in escalating doses

Group Type EXPERIMENTAL

SAR405838

Intervention Type DRUG

Pharmaceutical form: Capsule Route of administration: Oral

Interventions

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SAR405838

Pharmaceutical form: Capsule Route of administration: Oral

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No