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

NCT ID: NCT01943838

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

Brief Summary

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.

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.

Conditions

Neoplasm Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR245408 polymorph E tablets

Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles

Group Type: EXPERIMENTAL

SAR245408

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Interventions

SAR245408

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 056001

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2012-003368-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1132-9056

Identifier Type: OTHER

Identifier Source: secondary_id

TED12863

Identifier Type: -

Identifier Source: org_study_id