Clinical trial NCT01596270: A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: Dose Limiting Toxicities
timeFrame: Up to Day 28
Secondary outcomes:
measure: Number of patients with treatment-emergent adverse events
timeFrame: From first dose of SAR245409 until 30 days after the last dose
measure: Maximum SAR245409 plasma concentration
timeFrame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
measure: Area under the SAR245409 plasma concentration versus time curve
timeFrame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
measure: Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing
timeFrame: Days 1, 2, 3, and 4 of the food interaction period
measure: Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing
timeFrame: Days 1, 2, 3, and 4 of the food interaction period
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Investigational Site Number 840001
state: Michigan
city: New Brunswick
country: United States
facility: Investigational Site Number 840002
state: New Jersey
city: Dallas
country: United States
facility: Investigational Site Number 840003
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: