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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01852292
First Posted: May 13, 2013
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
May 8, 2013
May 13, 2013
November 29, 2017
October 1, 2013
March 30, 2017   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: at 4 weeks after study treatment start ]
To estimate the efficacy of buparlisib in combination with paclitaxel
Same as current
Complete list of historical versions of study NCT01852292 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
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
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)
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 is PFS and the key secondary endpoint is Overall Survival.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Head and Neck Squamous Cell Carcinoma
  • Drug: Paclitaxel
    Other Name: This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
  • Drug: Buparlisib
    Other Name: BKM120
  • Drug: Buparlisib Placebo
  • Experimental: Buparlisib + Paclitaxel
    buparlisib (BKM120) 100 mg daily + Paclitaxel
    Interventions:
    • Drug: Paclitaxel
    • Drug: Buparlisib
  • Placebo Comparator: Buparlisib matching placebo + Paclitaxel
    buparlisib matching placebo
    Interventions:
    • Drug: Paclitaxel
    • Drug: Buparlisib Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
March 30, 2017
March 30, 2017   (Final data collection date for primary outcome measure)

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);
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   France,   Germany,   Hungary,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Thailand,   United Kingdom,   United States
 
 
NCT01852292
CBKM120H2201
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP