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

Neoplasm Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943838
• Other study ID #: TED12863
• Secondary ID: 2012-003368-39U1
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2013
• Last updated: March 10, 2015
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Secondary Objectives:

• To evaluate the pharmacodynamic (PD) effect of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.

• To explore the antitumor activity of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• SAR245408
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056001	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities		Up to Day 28	Yes
Secondary	Number of patients with treatment-emergent adverse events		From first dose of SAR245408 up to 30 days after the last dose	Yes
Secondary	Maximum SAR245408 plasma concentration		Days 1, 2, 8, 15, 29 and 30	No
Secondary	Area under the SAR245408 plasma concentration versus time curve		Days 1, 2, 8, 15, 29 and 30	No