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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 2
18 Years
N/A
Not Enrolling
Both
Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

Thank you

Trial Information

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)


The primary endpoint is PFS and the key secondary endpoint is Overall Survival.


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 15 unstained slides to be
provided. Enrollment in the study is contingent on the central laboratory confirming
receipt of an adequate amount of 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);

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

To estimate the efficacy of buparlisib in combination with paclitaxel

Outcome Time Frame:

at 4 weeks after study treatment start

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120H2201

NCT ID:

NCT01852292

Start Date:

August 2013

Completion Date:

June 2015

Related Keywords:

  • Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
  • Head and neck squamous cell carcinoma,
  • recurrent,
  • metastatic,
  • BKM120
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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