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Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy

NCT01852292 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2018-07-24

Study results available
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Summary

Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.

Conditions

Interventions

DRUG

Buparlisib

Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day.

DRUG

Buparlisib matching Placebo

Buparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day.

DRUG

Paclitaxel

Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m\^2.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2017-03-30
Completion
2017-03-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Hungary
  • India
  • Ireland
  • Italy
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01852292 on ClinicalTrials.gov