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

Neoplasm Malignant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596270
• Other study ID #: TED12471
• Secondary ID: U1111-1123-1488
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• SAR245409
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
United States	Investigational Site Number 840003	Dallas	Texas
United States	Investigational Site Number 840001	Detroit	Michigan
United States	Investigational Site Number 840002	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities		Up to Day 28
Secondary	Number of patients with treatment-emergent adverse events		From first dose of SAR245409 until 30 days after the last dose
Secondary	Maximum SAR245409 plasma concentration		Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Secondary	Area under the SAR245409 plasma concentration versus time curve		Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Secondary	Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing		Days 1, 2, 3, and 4 of the food interaction period
Secondary	Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing		Days 1, 2, 3, and 4 of the food interaction period