A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma

NCT ID: NCT01596270

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-10-31

Brief Summary

Primary Objective:

• To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.

Secondary Objectives:

• To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
• To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
• To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
• To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire.
• To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.

Detailed Description

The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).

Conditions

Neoplasm Malignant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Once daily dosing

escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose

Group Type: EXPERIMENTAL

SAR245409

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Twice daily dosing

escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose

Group Type: EXPERIMENTAL

SAR245409

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Interventions

SAR245409

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.
• Male or female patient > or = 18 years old.
• Eastern Cooperative Oncology Group Performance Status < or = 1.
• Adequate white blood cells, platelets and haemoglobin.
• Adequate liver and kidney functions.
• Fasting plasma glucose < 160 mg/dL.
• No other malignancy.
• Women of childbearing potential using adequate contraception.

Exclusion Criteria

• History of partial or full gastrectomy.
• Lymphoma involving the gastrointestinal tract.
• Uncontrolled brain metastases or a primary brain tumor.
• 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 treatment.
• 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 treatment.
• Any other investigational therapy within 4 weeks before the first dose of study treatment.
• Prior anticancer hormonal therapy within 1 week before the first dose of study treatment.
• Prior radiation therapy within 2 weeks before the first dose of study treatment.
• Intolerance of prior treatment with a PI3K inhibitor.
• Hereditary or acquired immunodeficiency syndrome or HIV (human immunodeficiency virus) infection.
• Lymphoma patients with positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
• Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
• Patient is pregnant or breastfeeding.

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 840001

Detroit, Michigan, United States

Investigational Site Number 840002

New Brunswick, New Jersey, United States

Investigational Site Number 840003

Dallas, Texas, United States

Countries

United States

Other Identifiers

U1111-1123-1488

Identifier Type: OTHER

Identifier Source: secondary_id

TED12471

Identifier Type: -

Identifier Source: org_study_id