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NCT01751308 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01751308 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 39 participants.
The verdict
NCT01751308, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
Primary Objectives: Phase 1 Part: To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid tumors including tumors of the central nervous system. Phase 2 Part: To determine the objective response rate (complete and partial response) and the duration of response to cabazitaxel as a single agent in participants with recurrent or refractory high grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). Secondary Objectives: Phase 1 Part: To characterize the safety and tolerability of cabazitaxel in participants with recurrent or refractory solid tumors including tumors of the central nervous system. To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants with recurrent or refractory solid tumors including tumors of the central nervous system. To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in participants with recurrent or refractory solid tumors including tumors of the central nervous system. Phase 2 Part: To characterize the safety and tolerability of cabazitaxel in participants with recurrent or refractory HGG or DIPG. To estimate progression free survival in participants with recurrent or refractory HGG or DIPG. To estimate overall survival in participants with recurrent or refractory HGG or DIPG. To characterize the plasma PK profile of cabazitaxel in participants with recurrent or refractory HGG or DIPG.
Interventions
- DRUG Cabazitaxel (XRP6258)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01751308
The ClinicalTrials.gov registry entry for NCT01751308 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 Cabazitaxel (XRP6258) is the first listed.
NCT01751308 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01751308 about?
NCT01751308 is a clinical study titled "Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors". Primary Objectives: Phase 1 Part: To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid tumors including tumors of the central nervous system. Phase 2 Part: To determine the...
What is the current status of trial NCT01751308?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2013-02. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01751308?
The interventions under investigation include: Cabazitaxel (XRP6258) (DRUG).
Who is sponsoring clinical trial NCT01751308?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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