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Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck

NCT02113878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-11-05

Study results available
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Summary

This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Hypopharyngeal Cancer
  • Early Invasive Cervical Squamous Cell Carcinoma
  • Carcinoma of Larynx
  • Cancer of Nasopharynx

Interventions

DRUG

BKM120

BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.

DRUG

Cisplatin

Cisplatin is a chemotherapy drug

RADIATION

Intensity-modulated radiotherapy (IMRT)

IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells

Sponsors & Collaborators

Principal Investigators

  • Glenn J. Hanna, MD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-29
Primary Completion
2019-12-06
Completion
2022-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02113878 on ClinicalTrials.gov