Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02321501
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2014-12-17
Brief Title:
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase IIb Dose Escalation and Biomarker Study of Ceritinib LDK378 in Combination With Everolimus in Patients With Locally Advanced or Metastatic Solid Tumors With an Expansion in NSCLC Characterized by Abnormalities in Anaplastic Lymphoma Kinase ALK Expression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes locally advanced or to other places in the body metastatic or stage IIIB-IV non-small cell lung cancer Ceritinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
I To determine the maximum tolerated dose MTD of ceritinib novel potent and selective small molecule anaplastic lymphoma kinase ALK inhibitor in combination with everolimus a mammalian target of rapamycin mTOR inhibitor in advanced cancers
SECONDARY OBJECTIVES
I Preliminary descriptive assessment of the anti-tumor activity response rate of the combination in advanced non-small cell lung cancer NSCLC based upon Response Evaluation Criteria in Solid Tumors RECIST 11
II To determine the pharmacokinetics of ceritinib and everolimus used in combination
III To determine the safety of ceritinib and everolimus used in combination IV To evaluate the toxicities and tolerability of the combinations V To document anti-tumor activity disease control rate at 8 weeks and progression-free survival
EXPLORATORY OBJECTIVES
I To explore baseline molecular markers that may predict clinical activity and to explore pharmacodynamic markers in blood tumor tissue and molecular imaging that may predict an increase in apoptosis and clinical activity
II To determine concordance of ALK protein levels on immunohistochemistry fusion detection by fluorescence in situ hybridization FISH and somatic mutations
III To determine ribosomal protein S6 kinase S6K phosphorylation as a measure of mTOR inhibition
OUTLINE This is a dose-escalation study
Patients receive ceritinib orally PO once daily QD and everolimus PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 28 days
I To determine the maximum tolerated dose MTD of ceritinib novel potent and selective small molecule anaplastic lymphoma kinase ALK inhibitor in combination with everolimus a mammalian target of rapamycin mTOR inhibitor in advanced cancers
SECONDARY OBJECTIVES
I Preliminary descriptive assessment of the anti-tumor activity response rate of the combination in advanced non-small cell lung cancer NSCLC based upon Response Evaluation Criteria in Solid Tumors RECIST 11
II To determine the pharmacokinetics of ceritinib and everolimus used in combination
III To determine the safety of ceritinib and everolimus used in combination IV To evaluate the toxicities and tolerability of the combinations V To document anti-tumor activity disease control rate at 8 weeks and progression-free survival
EXPLORATORY OBJECTIVES
I To explore baseline molecular markers that may predict clinical activity and to explore pharmacodynamic markers in blood tumor tissue and molecular imaging that may predict an increase in apoptosis and clinical activity
II To determine concordance of ALK protein levels on immunohistochemistry fusion detection by fluorescence in situ hybridization FISH and somatic mutations
III To determine ribosomal protein S6 kinase S6K phosphorylation as a measure of mTOR inhibition
OUTLINE This is a dose-escalation study
Patients receive ceritinib orally PO once daily QD and everolimus PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-00062 | REGISTRY | None | None |
| 2014-0890 | OTHER | M D Anderson Cancer Center | None |