Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (PIK-ORL)
|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.|
|ClinicalTrials.gov Identifier: NCT01737450|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms Neoplasm Metastasis Recurrent Disease Progressive Disease||Drug: BKM120||Phase 2|
BKM120 is a PI3K inhibitor. The PI3K/Protein kinase B (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 phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter Trial Aiming to Evaluate the Clinical Interest of a Monotherapy With BKM120 , a Phosphoinositide 3-kinase (PI3K) Inhibitor in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive Under Platin and Cetuximab-based Chemotherapy|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||March 2019|
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.
Other Name: Buparlisib
- 2 months disease control rate [ Time Frame: 2 months after the first BKM120 intake ]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 ]
- Overall survival (OS) [ Time Frame: Baseline, at 2 months, 4 months and then every 2 months at the end of Study ]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 ]The assessment of safety will be based mainly on the frequency of adverse events based on the common toxicity criteria adverse event (CTCAE) V4.0 grade.
- Objective response rate [ Time Frame: At Baseline, 2 months, 4 months and then every 2 months, at the end of Study ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737450
|Hopital St André|
|Centre Oscar Lambret|
|Centre Léon Bérard|
|Centre Val d'Aurelle - Paul Lamarque|
|Centre Antoine LACASSAGNE|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69003|
|Institut Gustave Roussy|
|Principal Investigator:||Jérome FAYETTE, MD||Centre Léon Bérard, Lyon- FRANCE|