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COMPLETED Phase 1

Cabazitaxel - PF Induction Chemotherapy

NCT01379339 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2011-04
Est. Completion 2015-01
Phase Phase 1

Sponsor

Krzysztof Misiukiewicz

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01379339

The ClinicalTrials.gov registry entry for NCT01379339 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Krzysztof Misiukiewicz, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01379339 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01379339?

This trial is sponsored by Krzysztof Misiukiewicz, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial