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NCT01379339 · ClinicalTrials.gov registry record · Phase 1
Cabazitaxel - PF Induction Chemotherapy
A Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by Krzysztof Misiukiewicz.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01379339: Completed Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by Krzysztof Misiukiewicz.
NCT01379339 is a Phase 1 study of Squamous Cell Carcinoma of the Head and Neck that has completed, run by Krzysztof Misiukiewicz. The registered enrollment target is 40 participants, below the 145-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01379339, a Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by Krzysztof Misiukiewicz.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to determine the first-cycle maximum tolerated dose (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck for three cycles.
Primary Outcome
MTD is defined as the dose level immediately below the DLT. The study will be conducted until MTD and recommended Phase II dose are established.
Conditions Studied
Interventions
- DRUG Cabazitaxel 10mg/m2
- DRUG Cabazitaxel 12.5mg/m2
- DRUG Cabazitaxel 15mg/m2
- DRUG Cabazitaxel 17.5mg/m2
- DRUG Cabazitaxel 20mg/m2
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01379339 record still lists
NCT01379339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 145-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 5 interventions - of which Cabazitaxel 10mg/m2 is the first listed.
NCT01379339 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01379339 about?
NCT01379339 is a clinical study titled "Cabazitaxel - PF Induction Chemotherapy". The primary objective of this study is to determine the first-cycle maximum tolerated dose (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck for th...
What is the current status of trial NCT01379339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2011-04. Estimated completion is 2015-01.
What conditions does trial NCT01379339 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT01379339?
The interventions under investigation include: Cabazitaxel 10mg/m2 (DRUG), Cabazitaxel 12.5mg/m2 (DRUG), Cabazitaxel 15mg/m2 (DRUG), Cabazitaxel 17.5mg/m2 (DRUG), Cabazitaxel 20mg/m2 (DRUG).
Who is sponsoring clinical trial NCT01379339?
This trial is sponsored by Krzysztof Misiukiewicz, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01379339 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01379339's enrollment target sits among peer trials
40 20th of 29 higher than 8 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck 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.
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