Clinical trial NCT01943838: A Study of the Safety and Pharmacokinetics of SAR245408 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 SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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 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.

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 SAR245408 up to 30 days after the last dose
measure: Maximum SAR245408 plasma concentration
timeFrame: Days 1, 2, 8, 15, 29 and 30
measure: Area under the SAR245408 plasma concentration versus time curve
timeFrame: Days 1, 2, 8, 15, 29 and 30
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Investigational Site Number 056001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: