Try our beta test site

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01852292
First received: May 8, 2013
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Drug: Paclitaxel
Drug: Buparlisib
Drug: Buparlisib Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: at 4 weeks after study treatment start ]
    To estimate the efficacy of buparlisib in combination with paclitaxel


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: every 3 months for 2 years ]
    To assess the efficacy of the combination with paclitaxel in this patient population in terms of overall survival

  • Safety and Tolerability - frequency and severity of adverse events [ Time Frame: on an ongoing basis for a maximum of 2 years. ]
    To assess the safety and tolerability of buparlisib in combination with paclitaxel in this patient population

  • Overall Response Rate (ORR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ]
  • Time to Response (TTR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ]
  • Disease Control Rate (DCR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ]
  • Duration of Response (DoR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ]
  • Change from baseline in the global health status/QOL and pain scale scores of the EORTC QLQ-C30 and QLQ-HN35 [ Time Frame: baseline and every 6 weeks after randomization for 2 years . ]
    Percentage of change

  • Time to definitive 10% deterioration in the global health status/QOL (quality of life) [ Time Frame: baseline, and every 6 weeks after randomization for maximum for 2 years ]
  • Pain scale scores of the EORTC QLQ-C30 and QLQ-HN35 [ Time Frame: baseline, and every 6 weeks after randomization for maximum for 2 years ]
  • PK Sampling [ Time Frame: Cycle 1, Day1 of ecah cycle until Cycle 6 ]
    To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel


Enrollment: 157
Actual Study Start Date: October 1, 2013
Estimated Study Completion Date: April 28, 2017
Estimated Primary Completion Date: April 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buparlisib + Paclitaxel
buparlisib (BKM120) 100 mg daily + Paclitaxel
Drug: Paclitaxel
Other Name: This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
Drug: Buparlisib
Other Name: BKM120
Placebo Comparator: Buparlisib matching placebo + Paclitaxel
buparlisib matching placebo
Drug: Paclitaxel
Other Name: This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
Drug: Buparlisib Placebo

Detailed Description:
The primary endpoint is PFS and the key secondary endpoint is Overall Survival.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has histologically/cytologically-confirmed HNSCC.
  • Patient has archival or fresh tumor tissue for the analysis of PI3K-related biomarkers. One tumor block (preferred) or a minimum of 12 unstained slides to be provided. Enrollment in the study is contingent on confirmation of an adequate amount of tumor tissue.
  • Patients with recurrent or metastatic disease resistant to platinum-based chemotherapy (defined as progression while on platinum-based chemotherapy given in the recurrent/metastatic setting). Pretreatment with cetuximab is allowed
  • Measurable disease as determined by per RECIST criteria v1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a 4 week period since radiotherapy completion is required
  • Adequate bone marrow function and organ function
  • ECOG Performance Status ≤ 1

Exclusion Criteria:

  • Patient has received previous treatment with any AKT, mTOR inhibitors or PI3K pathway inhibitors;
  • Patient treated with more than one prior chemotherapy regimen for recurrent/metastatic disease
  • Patient has symptomatic CNS metastases. Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have stable low dose of corticosteroid therapy;
  • Patient has not recovered to ≤ grade 1 (except alopecia) from related side effects of any prior antineoplastic therapy
  • Patient has any of the following cardiac abnormalities:symptomatic congestive heart failure, history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy, Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO); myocardial infarction ≤ 6 months prior to enrolment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, QTcF > 480 msec on the screening ECG (using the QTcF formula);
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852292

  Show 58 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01852292     History of Changes
Other Study ID Numbers: CBKM120H2201
Study First Received: May 8, 2013
Last Updated: March 16, 2017

Keywords provided by Novartis:
platinum pre-treated recurrent or metastatic
Head and neck squamous cell carcinoma,
recurrent
metastatic
BKM120

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 22, 2017