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NCT Number: NCT01596270

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

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.

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Key information

Conditions

Neoplasm Malignant Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 840001, Detroit, Michigan, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR245409

Drug

Pharmaceutical form: tablet Route of administration: oral

Primary outcomes

  1. Dose Limiting Toxicities

    Time frame: Up to Day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 10, 2012
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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