A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01943838

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Malignant	Drug: SAR245408	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAR245408 polymorph E tablets Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles	Drug: SAR245408 Pharmaceutical form: tablet Route of administration: oral

Arm

Intervention/Treatment

Experimental: SAR245408 polymorph E tablets

Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles

Drug: SAR245408

Pharmaceutical form: tablet Route of administration: oral

Outcome Measures

Primary Outcome Measures

Dose Limiting Toxicities [Up to Day 28]

Secondary Outcome Measures

Number of patients with treatment-emergent adverse events [From first dose of SAR245408 up to 30 days after the last dose]
Maximum SAR245408 plasma concentration [Days 1, 2, 8, 15, 29 and 30]
Area under the SAR245408 plasma concentration versus time curve [Days 1, 2, 8, 15, 29 and 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 056001	Leuven		Belgium	3000

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT01943838

Other Study ID Numbers:

TED12863
2012-003368-39
U1111-1132-9056

First Posted:

Sep 17, 2013

Last Update Posted:

Apr 22, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Apr 22, 2016