Neoplasm Metastasis Clinical Trial
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03775980 -
CIRSE Emprint Microwave Ablation Registry
|
||
| Completed |
NCT01114958 -
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
|
Phase 1 | |
| Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
| Active, not recruiting |
NCT04458259 -
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
|
Phase 1 | |
| Completed |
NCT01218542 -
Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc
|
N/A | |
| Not yet recruiting |
NCT03175146 -
A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
|
N/A | |
| Active, not recruiting |
NCT02395224 -
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
|
||
| Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
| Recruiting |
NCT01960829 -
Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study
|
Phase 2 | |
| Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
| Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
| Recruiting |
NCT01564810 -
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
|
Phase 4 | |
| Completed |
NCT00375245 -
Rapamycin With Grapefruit Juice for Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00232726 -
Clinical Study of Previously Untreated Patients With Malignant Melanoma
|
Phase 2 | |
| Completed |
NCT00207116 -
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
|
Phase 1 | |
| Completed |
NCT00207103 -
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00172003 -
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
|
Phase 4 |