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

A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma

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.

Study Overview

• Status: Completed
• Conditions: Neoplasm Malignant
• Intervention / Treatment: Drug: SAR245409

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).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Investigational Site Number 840001
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Investigational Site Number 840002
  • Texas
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 840003

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Once daily dosing; escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose	Drug: SAR245409; Pharmaceutical form: tablet Route of administration: oral
Experimental: Twice daily dosing; escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose	Drug: SAR245409; 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 SAR245409 until 30 days after the last dose
Maximum SAR245409 plasma concentration	Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Area under the SAR245409 plasma concentration versus time curve	Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing	Days 1, 2, 3, and 4 of the food interaction period
Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing	Days 1, 2, 3, and 4 of the food interaction period

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TED12471; U1111-1123-1488 (Other Identifier: UTN)