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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01943838
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: SAR245408 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943838


Locations
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Belgium
Investigational Site Number 056001
Leuven, Belgium, 3000
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01943838    
Other Study ID Numbers: TED12863
2012-003368-39 ( EudraCT Number )
U1111-1132-9056 ( Other Identifier: UTN )
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Neoplasms