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MLN8237 in Head and Neck Cancer

NCT01540682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-08-29

No results posted yet for this study

Summary

This study will evaluate the initial safety and effectiveness of an investigational drug, MLN8237, added to routine radiation therapy and cetuximab in patients with head and neck cancer. This study will also determine the highest dose of MLN8237 that can be given together with cetuximab and radiation therapy without causing severe side effects.

Conditions

Interventions

DRUG

MLN8237

Three dose levels of MLN8237 are planned:30, 40 and 50 mg po bid.

DRUG

Cetuximab

\~ 1 week prior to the initiation of radiation therapy and continuing for a grand total of 12 weeks.

RADIATION

Radiotherapy

Radiotherapy will be administered in 2-Gy fractions, 5 days a week to a total dose of \~70 Gy.

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Roger Cohen, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540682 on ClinicalTrials.gov