Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (PIK-ORL)
The aim of this study is to determine the activity, to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under patin and cetuximab-based chemotherapy.
Head and Neck Neoplasms
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Multicenter Trial Aiming to Evaluate the Clinical Interest of a Monotherapy With BKM120 , a PI3K Inhibitor in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive Under Platin and Cetuximab-based Chemotherapy|
- 2 months disease control rate [ Time Frame: 2 months after the first BKM120 intake ] [ Designated as safety issue: No ]Control rate= Complete response, partial response and stable disease according to RECIST 1.1
- Progression free survival [ Time Frame: At 2 months, 4 months and then every 2 months ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: Baseline, at 2 months, 4 months and then every 2 months at the end of Study ] [ Designated as safety issue: No ]OS will be measured from the date of inclusion to the date of death from any cause.
- Safety [ Time Frame: continuous up to 30 days after the last treatment ] [ Designated as safety issue: No ]The assessment of safety will be based mainly on the frequency of adverse events based on the common toxicity criteria (CTC-AE V4.0) grade.
- Objective response rate [ Time Frame: At Baseline, 2 months, 4 months and then every 2 months, at the end of Study ] [ Designated as safety issue: No ]Objective response rate is defined as the proportion of patient with complete or partial response according RECIST 1.1
- Duration of response [ Time Frame: At Baseline, 2 months, 4months and then every 2 months, at the end of Study ] [ Designated as safety issue: No ]The duration of response will be measured from the time of first documented response until the first documented disease progression or death due to underlying cancer.
- Time to Progression [ Time Frame: At Baseline, 2 months, 4months and then every 2 months, at the end of Study ] [ Designated as safety issue: No ]Time to Progression will be measured from the time of treatment start until the first documented disease progression. Patients with no event at the time of the analysis will be censored at their last tumor assessment date.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Full dose=100 mg/day (oral route) One study cycle equals 28 days. Patients will be treated until disease progression, unacceptable toxicity, or willingness to stop.
BKM120 is a PI3K inhibitor. The PI3K/AKT signalling pathway deregulation is frequently observed in Head and neck cancer. In addition to its role in tumor genesis, the PI3K/AKT pathway seems to be involved in resistance to cetuximab.
In this context, the study proposal is to evaluate the clinical interest of a monotherapy with a PI3K inhibitor (BKM120, Novartis) in patients with metastatic head and neck cancers refractory or relapsing under platin and cetuximab based- chemotherapy. Since resistance to cetuximab can result from PIK3CA mutation, PIK3CA amplification or mutation upstream in the PI3K pathway, BKM120 activity will be evaluated in two parallel independent cohorts of patients: patients presenting a PI3KCA mutation and patients without a PI3KCA mutation.
|Contact: Jérôme FAYETTE, MDfirstname.lastname@example.org|
|Hopital St André||Recruiting|
|Contact: Alain Ravaud 05 56 79 58 08 email@example.com|
|Principal Investigator: Alain RAVAUD|
|Sub-Investigator: Laurence DIGUE|
|Hôpital BEAUJON||Not yet recruiting|
|Contact: Sandrine FAIVRE, MD firstname.lastname@example.org|
|Centre Oscar Lambret||Recruiting|
|Contact: Mariam DEGARDIN, MD email@example.com|
|Centre Léon Bérard||Recruiting|
|Contact: Jérome FAYETTE, MD firstname.lastname@example.org|
|Centre Val d'Aurelle - Paul Lamarque||Recruiting|
|Contact: Didier CUPISSOL, MD email@example.com|
|Centre Antoine LACASSAGNE||Recruiting|
|Contact: Frédéric PEYRADE, MD firstname.lastname@example.org|
|Contact: Christophe LETOURNEAU, MD email@example.com|
|Institut Gustave Roussy||Not yet recruiting|
|Contact: Joël GUIGAY, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Jérome FAYETTE, MD||Centre Léon Bérard, Lyon- FRANCE|