Overview

This trial is active, not recruiting.

Condition neoplasm malignant
Treatment sar405838
Phase phase 1
Sponsor Sanofi
Start date July 2012
End date December 2016
Trial size 82 participants
Trial identifier NCT01636479, 2012-000733-39, TED12318, U1111-1127-2911

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SAR405838 in escalating doses
sar405838
Pharmaceutical form: Capsule Route of administration: Oral

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sanofi.