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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: Completed Phase 1 study, sponsored by Sanofi.
NCT01751308 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic
Interventions
- DRUG Cabazitaxel (XRP6258)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT01751308 record still lists
NCT01751308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Cabazitaxel (XRP6258) is the first listed.
NCT01751308 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751308's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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