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

Sanofi

Status and phase

Completed

Phase 1

Conditions

Neoplasm Malignant

Treatments

Drug: SAR245408

Study type

Interventional

Funder types

Industry

Identifiers

NCT01943838

2012-003368-39 (EudraCT Number)

TED12863

U1111-1132-9056 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.