A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma
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|ClinicalTrials.gov Identifier: NCT01943838|
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : April 22, 2016
- 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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||October 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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
Pharmaceutical form: tablet Route of administration: oral
- Dose Limiting Toxicities [ Time Frame: Up to Day 28 ]
- Number of patients with treatment-emergent adverse events [ Time Frame: From first dose of SAR245408 up to 30 days after the last dose ]
- Maximum SAR245408 plasma concentration [ Time Frame: Days 1, 2, 8, 15, 29 and 30 ]
- Area under the SAR245408 plasma concentration versus time curve [ Time Frame: Days 1, 2, 8, 15, 29 and 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943838
|Investigational Site Number 056001|
|Leuven, Belgium, 3000|
|Study Director:||Clinical Sciences & Operations||Sanofi|