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NCT01596270 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT01596270 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 49 participants.
The verdict
NCT01596270, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study 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.
Interventions
- DRUG SAR245409
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01596270
The ClinicalTrials.gov registry entry for NCT01596270 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAR245409 is the first listed.
NCT01596270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01596270 about?
NCT01596270 is a clinical study titled "A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma". 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 wi...
What is the current status of trial NCT01596270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-06. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01596270?
The interventions under investigation include: SAR245409 (DRUG).
Who is sponsoring clinical trial NCT01596270?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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