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NCT01711541 · ClinicalTrials.gov registry record · Phase 1

Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer

A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
5
Study locations

NCT01711541 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 3 states.

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The verdict

NCT01711541, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
5
Study locations

Study Summary

This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and to see how well they work in treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given with or without veliparib in treating head and neck cancer.

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Fluorouracil
  • DRUG Hydroxyurea
  • OTHER Laboratory Biomarker Analysis

Study Locations (5)

Illinois

  • Northwestern University - Chicago
  • University of Chicago Comprehensive Cancer Center - Chicago
  • NorthShore University HealthSystem-Evanston Hospital - Evanston

Missouri

  • Washington University School of Medicine - St Louis

North Carolina

  • UNC Lineberger Comprehensive Cancer Center - Chapel Hill

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2012-10-22
Est. Completion 2023-05-15
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01711541

The ClinicalTrials.gov registry entry for NCT01711541 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (79% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT01711541 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Missouri, North Carolina.

Frequently Asked Questions

What is clinical trial NCT01711541 about?

NCT01711541 is a clinical study titled "Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer". This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and to see how well they work in treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluoro...

What is the current status of trial NCT01711541?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-10-22. Estimated completion is 2023-05-15.

What conditions does trial NCT01711541 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Stage IVA Oropharyngeal Carcinoma AJCC v7, Stage IVB Oropharyngeal Carcinoma AJCC v7.

What interventions are being tested in trial NCT01711541?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Hydroxyurea (DRUG), Laboratory Biomarker Analysis (OTHER).

Who is sponsoring clinical trial NCT01711541?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01711541 being conducted?

This trial has 5 study locations across Illinois, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.