A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma

A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma

Primary Objective:

- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.

Study Overview

• Status: Completed
• Conditions: Neoplasm Malignant
• Intervention / Treatment: Drug: SAR245408

Detailed Description

Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.

Total duration of study participation for each patient: 58 to 118 days.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Investigational Site Number 056001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival or patient cannot tolerate or has contra-indication for a standard therapy and there is no alternative therapies.
• Male or female patient > or = 18 years old.
• Weight > or = 40 kg.
• Eastern Cooperative Oncology Group performance status < or = 1.
• Adequate white blood cells, platelets, and haemoglobin.
• Adequate liver and kidney functions.
• Fasting plasma glucose < 8.9 mmol/L.
• Sexually active patients using adequate contraception.
• Women of child-bearing potential with negative pregnancy test.

Exclusion criteria:

• Lymphoma involving the gastrointestinal tract.
• Prior treatment with cytotoxic chemotherapy (including investigational agents) or biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks, before the first dose of study drug.
• Prior treatment with a small-molecule kinase inhibitor (including investigational agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever is longer, before the first dose of study drug.
• Any other investigational therapy within 4 weeks before the first dose of study drug.
• Intolerance to prior treatment with a PI3K inhibitor.
• Prior anticancer hormonal therapy within 2 weeks before the first dose of study drug.
• Prior radiation therapy within 2 weeks before the first dose of study drug.
• Uncontrolled brain metastases or primary brain tumor.
• Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection.
• Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
• Patient is pregnant or breastfeeding.
• History of gastrointestinal surgery, or presence of gastrointestinal abnormality or disease, that may affect the pharmacokinetics of study drug.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SAR245408 polymorph E tablets; Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles	Drug: SAR245408; Pharmaceutical form: tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Limiting Toxicities	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with treatment-emergent adverse events	From first dose of SAR245408 up to 30 days after the last dose
Maximum SAR245408 plasma concentration	Days 1, 2, 8, 15, 29 and 30
Area under the SAR245408 plasma concentration versus time curve	Days 1, 2, 8, 15, 29 and 30

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (ESTIMATE): September 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TED12863; 2012-003368-39 (EUDRACT_NUMBER); U1111-1132-9056 (OTHER: UTN)