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

NCT01943838 | Completed Phase 1

• 3 other identifiers: TED128632012-003368-39U1111-1132-9056
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities

  Up to Day 28

Secondary Outcomes (3)

• Number of patients with treatment-emergent adverse events

  From first dose of SAR245408 up to 30 days after the last dose

• Maximum SAR245408 plasma concentration

  Days 1, 2, 8, 15, 29 and 30

• Area under the SAR245408 plasma concentration versus time curve

  Days 1, 2, 8, 15, 29 and 30

Study Arms (1)

SAR245408 polymorph E tablets

EXPERIMENTAL

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

Drug: SAR245408

Interventions

SAR245408 DRUG

Pharmaceutical form: tablet Route of administration: oral

SAR245408 polymorph E tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 056001

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

XL147

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

BE (1)