A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01596270
First received: May 9, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Neoplasm Malignant
Drug: SAR245409
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose Limiting Toxicities [ Time Frame: Up to Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with treatment-emergent adverse events [ Time Frame: From first dose of SAR245409 until 30 days after the last dose ] [ Designated as safety issue: Yes ]
  • Maximum SAR245409 plasma concentration [ Time Frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing [ Time Frame: Days 1, 2, 3, and 4 of the food interaction period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  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: NCT01596270

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01596270     History of Changes
Other Study ID Numbers: TED12471, U1111-1123-1488
Study First Received: May 9, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014