Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive
NCT ID: NCT01737450
Last Updated: 2019-06-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
58 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-01-31
Study Completion Date
2019-03-31
Brief Summary
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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 platin and cetuximab-based chemotherapy.
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Detailed Description
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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.
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.
Conditions
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Head and Neck Neoplasms
Neoplasm Metastasis
Recurrent Disease
Progressive Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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BKM120
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.
Group Type
EXPERIMENTAL
BKM120
Intervention Type
DRUG
Interventions
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BKM120
Intervention Type
DRUG
Other Intervention Names
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Buparlisib
Eligibility Criteria
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Inclusion Criteria
* 1\. Adult men and women ≥ 18 years at the day of inform consent signature.
* 2\. Patients with metastatic or relapsed squamous cell head and neck carcinoma .
* 3\. Documented progression or relapse after platin and cetuximab or anti-epidermal growth factor receptor (EGFR) -based chemotherapy at time of study drug start
* 4\. Documented mutational status of PIK3CA before study drug start
* 5\. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 .
* 6\. At least one measurable lesion by CT-scan as per RECIST 1.1 .
* 7\. Life expectancy \> 12 weeks.
* 8\. Patients must be able to swallow capsules.
* 9\. Adequate bone marrow, renal and liver function as defined by the following tests :
* Absolute neutrophil count ≥ 1.0 x 109/L,
* Platelet count \> 100 x 109/L,
* Haemoglobin value above 9 g/dL,
* international normalized ratio (INR) ≤ 1.5
* Serum Creatinine ≤ 1.5 upper limit of normal (ULN)
* Glomerular filtration rate calculated using Cockcroft-Gault formula \> 60ml/min (or MDRD formula for patients older than 65 years)
* Potassium, calcium, magnesium within normal limits for the institution
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< ULN (or \< 3.0 x ULN if liver metastases are present))
* Serum bilirubin within normal range (or ≤ 1.5 ULN if liver metastases are present; or total bilirubin ≤ 3.0 ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
* Fasting plasma glucose (FPG) ≤ 120 mg/dL or ≤ 6.7 mmol/L.
* 10\. Women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test within ≤ 72 hours before initiating study treatment) must agree to use two methods of medically acceptable forms of contraception during the whole treatment period and for 1 month (= 5 x t½ of BKM120) after the last treatment intake.
* 11\. Fertile males must use a highly effective contraception during dosing of any study agent + \[5 x t1/2\] + 12 weeks = contraception through 16 weeks after final dose of study therapy and should not father a child in this period. Female partner of male study subject: highly effective contraception during dosing of study agent + 4 weeks after final dose of study therapy
* 12\. Patient should be able and willing to comply with study visits and procedures as per protocol.
* 13\. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
* 14\. Patients must be covered by a medical insurance.
* 2\. Patients with metastatic or relapsed squamous cell head and neck carcinoma .
* 3\. Documented progression or relapse after platin and cetuximab or anti-epidermal growth factor receptor (EGFR) -based chemotherapy at time of study drug start
* 4\. Documented mutational status of PIK3CA before study drug start
* 5\. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 .
* 6\. At least one measurable lesion by CT-scan as per RECIST 1.1 .
* 7\. Life expectancy \> 12 weeks.
* 8\. Patients must be able to swallow capsules.
* 9\. Adequate bone marrow, renal and liver function as defined by the following tests :
* Absolute neutrophil count ≥ 1.0 x 109/L,
* Platelet count \> 100 x 109/L,
* Haemoglobin value above 9 g/dL,
* international normalized ratio (INR) ≤ 1.5
* Serum Creatinine ≤ 1.5 upper limit of normal (ULN)
* Glomerular filtration rate calculated using Cockcroft-Gault formula \> 60ml/min (or MDRD formula for patients older than 65 years)
* Potassium, calcium, magnesium within normal limits for the institution
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< ULN (or \< 3.0 x ULN if liver metastases are present))
* Serum bilirubin within normal range (or ≤ 1.5 ULN if liver metastases are present; or total bilirubin ≤ 3.0 ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
* Fasting plasma glucose (FPG) ≤ 120 mg/dL or ≤ 6.7 mmol/L.
* 10\. Women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test within ≤ 72 hours before initiating study treatment) must agree to use two methods of medically acceptable forms of contraception during the whole treatment period and for 1 month (= 5 x t½ of BKM120) after the last treatment intake.
* 11\. Fertile males must use a highly effective contraception during dosing of any study agent + \[5 x t1/2\] + 12 weeks = contraception through 16 weeks after final dose of study therapy and should not father a child in this period. Female partner of male study subject: highly effective contraception during dosing of study agent + 4 weeks after final dose of study therapy
* 12\. Patient should be able and willing to comply with study visits and procedures as per protocol.
* 13\. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
* 14\. Patients must be covered by a medical insurance.
Exclusion Criteria
* 1\. Patient having received previous treatment with PI3K and/or mammilian target of rapamycin (mTOR) inhibitors.
* 2\. Patient with symptomatic central nervous system (CNS) metastases.
* 3\. Patient with a concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
* 4\. Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist:
* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others),
* Patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual (DSM) - IV) are not eligible.
Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug.
* ≥ CTCAE grade 3 anxiety,
* or meets the cut-off score of ≥ 12 in the Patient Health Questionnaire (PHQ) -9 or a cut-off of ≥ 15 in the generalized anxiety disorder (GAD) -7 mood scale, respectively,
* or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9).
* 5\. Patient concurrently using other approved or investigational anti-neoplasic agent.
* 6\. Patient who has received anticancer therapy \< 2 weeks or investigational treatment \< 4 weeks prior the initiation of study drug.
* 7\. Patient who has received radiotherapy ≤ 4 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia).
* 8\. Patient having had major surgery within 14 days prior to starting study drug or has not recovered from major side effects of the surgery.
* 9\. Patient with poorly controlled diabetes mellitus (i.e. HbA1c \> 8 %)
* 10\. Patient with active cardiac disease including any of the following:
* Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO),
* corrected QT interval (QTc) \> 480 (female) or 470 msec (male) on screening ECG (using the corrected QT Fridericia (QTcF) formulae),
* Angina pectoris that requires the use of anti-anginal medication,
* Ventricular arrhythmias except for benign premature ventricular contractions,
* Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication,
* Conduction abnormality requiring a pacemaker,
* Valvular disease with documented compromise in cardiac function,
* Symptomatic pericarditis.
* 11\. Patient with a history of cardiac dysfunction including any of the following:
* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function,
* History of documented congestive heart failure (New York Heart Association functional classification III-IV),
* Documented cardiomyopathy,
* Other cardiac arrhythmia not controlled with medication.
* 12\. Patient currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and if the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
* 13\. Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
* 14\. Patient receiving chronic treatment (\> 5 days) with steroids or another immunosuppressive agent. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g., dexamethasone 2 mg/day, prednisolone 10 mg/day) for at least 14 days before start of study treatment, are eligible.
* 15\. Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study
* 16\. Patient has a history of non-compliance to medical regimen.
* 17\. Patient is currently being treated with drugs known to be strong inhibitors or inducers of isoenzyme Cytochrome P450 family 3 subfamily A member 4 (CYP3A), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
* 18\. Patient has a known history of HIV infection.
* 19\. Pregnant or nursing (lactating) woman.
* 20\. Patient has a known hypersensitivity to any of the excipients of BKM120.
* 21\. Patient has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy.
* 22\. Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin, or fondaparinux is allowed.
* 23\. Patient has acute viral hepatitis or a history of chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, typically defined by elevated AST/ALT (persistent or intermittent), high HBV DNA level, HBsAg positive, or high HCV RNA level (testing not mandatory)
* 2\. Patient with symptomatic central nervous system (CNS) metastases.
* 3\. Patient with a concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
* 4\. Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist:
* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others),
* Patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual (DSM) - IV) are not eligible.
Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug.
* ≥ CTCAE grade 3 anxiety,
* or meets the cut-off score of ≥ 12 in the Patient Health Questionnaire (PHQ) -9 or a cut-off of ≥ 15 in the generalized anxiety disorder (GAD) -7 mood scale, respectively,
* or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9).
* 5\. Patient concurrently using other approved or investigational anti-neoplasic agent.
* 6\. Patient who has received anticancer therapy \< 2 weeks or investigational treatment \< 4 weeks prior the initiation of study drug.
* 7\. Patient who has received radiotherapy ≤ 4 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia).
* 8\. Patient having had major surgery within 14 days prior to starting study drug or has not recovered from major side effects of the surgery.
* 9\. Patient with poorly controlled diabetes mellitus (i.e. HbA1c \> 8 %)
* 10\. Patient with active cardiac disease including any of the following:
* Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO),
* corrected QT interval (QTc) \> 480 (female) or 470 msec (male) on screening ECG (using the corrected QT Fridericia (QTcF) formulae),
* Angina pectoris that requires the use of anti-anginal medication,
* Ventricular arrhythmias except for benign premature ventricular contractions,
* Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication,
* Conduction abnormality requiring a pacemaker,
* Valvular disease with documented compromise in cardiac function,
* Symptomatic pericarditis.
* 11\. Patient with a history of cardiac dysfunction including any of the following:
* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function,
* History of documented congestive heart failure (New York Heart Association functional classification III-IV),
* Documented cardiomyopathy,
* Other cardiac arrhythmia not controlled with medication.
* 12\. Patient currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and if the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
* 13\. Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
* 14\. Patient receiving chronic treatment (\> 5 days) with steroids or another immunosuppressive agent. Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g., dexamethasone 2 mg/day, prednisolone 10 mg/day) for at least 14 days before start of study treatment, are eligible.
* 15\. Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study
* 16\. Patient has a history of non-compliance to medical regimen.
* 17\. Patient is currently being treated with drugs known to be strong inhibitors or inducers of isoenzyme Cytochrome P450 family 3 subfamily A member 4 (CYP3A), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
* 18\. Patient has a known history of HIV infection.
* 19\. Pregnant or nursing (lactating) woman.
* 20\. Patient has a known hypersensitivity to any of the excipients of BKM120.
* 21\. Patient has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy.
* 22\. Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin, or fondaparinux is allowed.
* 23\. Patient has acute viral hepatitis or a history of chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, typically defined by elevated AST/ALT (persistent or intermittent), high HBV DNA level, HBsAg positive, or high HCV RNA level (testing not mandatory)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Sponsor Role
collaborator
Fondation ARC
OTHER
Sponsor Role
collaborator
Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jérome FAYETTE, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Léon Bérard, Lyon- FRANCE
Locations
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Hopital St André
Bordeaux, , France
Site Status
Hôpital BEAUJON
Clichy, , France
Site Status
Centre Oscar Lambret
Lille, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Centre Val d'Aurelle - Paul Lamarque
Montpellier, , France
Site Status
Centre Antoine LACASSAGNE
Nice, , France
Site Status
Institut Curie
Paris, , France
Site Status
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
Countries
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France
References
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Graupera M, Guillermet-Guibert J, Foukas LC, Phng LK, Cain RJ, Salpekar A, Pearce W, Meek S, Millan J, Cutillas PR, Smith AJ, Ridley AJ, Ruhrberg C, Gerhardt H, Vanhaesebroeck B. Angiogenesis selectively requires the p110alpha isoform of PI3K to control endothelial cell migration. Nature. 2008 May 29;453(7195):662-6. doi: 10.1038/nature06892. Epub 2008 Apr 30.
Reference Type
BACKGROUND
Schnell CR, Stauffer F, Allegrini PR, O'Reilly T, McSheehy PM, Dartois C, Stumm M, Cozens R, Littlewood-Evans A, Garcia-Echeverria C, Maira SM. Effects of the dual phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor NVP-BEZ235 on the tumor vasculature: implications for clinical imaging. Cancer Res. 2008 Aug 15;68(16):6598-607. doi: 10.1158/0008-5472.CAN-08-1044.
Reference Type
BACKGROUND
Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. doi: 10.1056/NEJM199301213280306. No abstract available.
Reference Type
BACKGROUND
Saranath D, Panchal RG, Nair R, Mehta AR, Sanghavi VD, Deo MG. Amplification and overexpression of epidermal growth factor receptor gene in human oropharyngeal cancer. Eur J Cancer B Oral Oncol. 1992 Oct;28B(2):139-43. doi: 10.1016/0964-1955(92)90043-z.
Reference Type
BACKGROUND
Burtness B. The role of cetuximab in the treatment of squamous cell cancer of the head and neck. Expert Opin Biol Ther. 2005 Aug;5(8):1085-93. doi: 10.1517/14712598.5.8.1085.
Reference Type
BACKGROUND
Other Identifiers
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2012-002403-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ET12-034
Identifier Type: -
Identifier Source: org_study_id
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