Status:
TERMINATED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 thera...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2017
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01852292
Start Date
October 1 2013
End Date
March 30 2017
Last Update
July 24 2018
Active Locations (58)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Dana Farber Cancer Institute IRB
Boston, Massachusetts, United States, 02215
3
Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201
St Louis, Missouri, United States, 63110
4
The Mount Sinai Hospital Dept of Oncology
New York, New York, United States, 10029