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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01943838
First received: September 12, 2013
Last updated: April 21, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention Phase
Neoplasm Malignant Drug: SAR245408 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose Limiting Toxicities [ Time Frame: Up to Day 28 ]

Secondary Outcome Measures:
  • Number of patients with treatment-emergent adverse events [ Time Frame: From first dose of SAR245408 up to 30 days after the last dose ]
  • Maximum SAR245408 plasma concentration [ Time Frame: Days 1, 2, 8, 15, 29 and 30 ]
  • Area under the SAR245408 plasma concentration versus time curve [ Time Frame: Days 1, 2, 8, 15, 29 and 30 ]

Enrollment: 18
Study Start Date: October 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR245408 polymorph E tablets
Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles
Drug: SAR245408
Pharmaceutical form: tablet Route of administration: oral

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943838

Locations
Belgium
Investigational Site Number 056001
Leuven, Belgium, 3000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01943838     History of Changes
Other Study ID Numbers: TED12863
2012-003368-39 ( EudraCT Number )
U1111-1132-9056 ( Other Identifier: UTN )
Study First Received: September 12, 2013
Last Updated: April 21, 2016

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 28, 2017