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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01852292
First received: May 8, 2013
Last updated: June 10, 2014
Last verified: June 2014
  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
Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
Drug: Paclitaxel
Drug: Buparlisib
Drug: Buparlisib Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    To estimate the efficacy of buparlisib in combination with paclitaxel


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: every 3 months for 2 years ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
  • Time to Response (TTR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • Duration of Response (DoR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • 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 . ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • PK Sampling [ Time Frame: Cycle 1, Day1 of ecah cycle until Cycle 6 ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 75 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01852292     History of Changes
Other Study ID Numbers: CBKM120H2201
Study First Received: May 8, 2013
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: ANSM
Germany: BfarM
Hungary: National Institute of Pharmacy
Italy: AIFA
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
South Korea: Food and Drug Administration
Spain: Agency of Medecines & Health Products
Switzerland: Swissmedic
Taiwan: Center for Drug Evaluation
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Indian Council of Medical Research
Ireland:Health & Safety Authority

Keywords provided by Novartis:
Head and neck squamous cell carcinoma,
recurrent,
metastatic,
BKM120

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

ClinicalTrials.gov processed this record on November 27, 2014