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A Study of the Safety and Pharmacokinetics of SAR245409 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: NCT01596270
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: SAR245409 Phase 1

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  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : June 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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



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 SAR245409 until 30 days after the last dose ]
  2. Maximum SAR245409 plasma concentration [ Time Frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 ]
  3. Area under the SAR245409 plasma concentration versus time curve [ Time Frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 ]
  4. Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing [ Time Frame: Days 1, 2, 3, and 4 of the food interaction period ]
  5. Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing [ Time Frame: Days 1, 2, 3, and 4 of the food interaction period ]


Information from the National Library of Medicine

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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.
  • 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.


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): NCT01596270


Locations
United States, Michigan
Investigational Site Number 840001
Detroit, Michigan, United States, 48201
United States, New Jersey
Investigational Site Number 840002
New Brunswick, New Jersey, United States, 08903
United States, Texas
Investigational Site Number 840003
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01596270     History of Changes
Other Study ID Numbers: TED12471
U1111-1123-1488 ( Other Identifier: UTN )
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Neoplasms