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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004632-29 | EudraCT Number |
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The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDK378 and AUY922 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDK378 | Drug | LDK378 is a capsule to be taken daily by mouth. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Dose Limiting Toxicities (DLT) | cycle = within the first 28 days of patient's first dose | up to day 28 after the patient's first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Characterize the safety and tolerability of LDK378 and AUY922 in patients | 30 months |
| Changes in laboratory values | Characterize the safety and tolerability of LDK378 and AUY922 in patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Dept. of Anschutz Cancer (3) | Aurora | Colorado | 80045 | United States | ||
| Massachusetts General Hospital Mass General |
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| Label | URL |
|---|---|
| Results for CLDK378X2102 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C586847 | ceritinib |
| C528044 | 5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide |
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| AUY922 |
| Drug |
AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis. |
|
| 30 months |
| Assessments of electrocardiograms | Characterize the safety and tolerability of LDK378 and AUY922 in patients | 30 months |
| Assessments of dose interruptions, reductions, and dose intensity | Characterize the safety and tolerability of LDK378 and AUY922 in patients | 30 months |
| Plasma PK parameter of LDK378 and AUY922: Tmax | Characterize single and multiple dose PK of LDK378 and AUY922 in patients | 30 months |
| Overall response rate (ORR) | Assess the anti-tumor activity of LDK378 and AUY922 | 30 months |
| Duration of Response (DoR) | Assess the anti-tumor activity of LDK378 and AUY922 | 30 months |
| Time to Response (TTR) | Assess the anti-tumor activity of LDK378 and AUY922 | 30 months |
| Progression free survival (PFS) | Assess the anti-tumor activity of LDK378 and AUY922 per RECIST 1.1 | 30 months |
| Number of patients with serious adverse events | Characterize the safety and tolerability of LDK378 and AUY922 in patients | 30 months |
| Plasma PK parameter of LDK378 and AUY922: Cmax | Characterize single and multiple dose PK of LDK378 and AUY922 in patients | 30 months |
| Plasma PK parameter of LDK378 and AUY922: AUClast | Characterize single and multiple dose PK of LDK378 and AUY922 in patients | 30 months |
| Plasma PK parameter of LDK378 and AUY922: AUCtau | Characterize single and multiple dose PK of LDK378 and AUY922 in patients | 30 months |
| Plasma PK parameter of LDK378 and AUY922: Cmin | Characterize single and multiple dose PK of LDK378 and AUY922 in patients | 30 months |
| Plasma PK parameter of LDK378 and AUY922: Racc | Characterize single and multiple dose PK of LDK378 and AUY922 in patients | 30 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Fox Chase Cancer Center Fox Chase Cancer (2) | Philadelphia | Pennsylvania | 19111-2497 | United States |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City | Utah | 84103 | United States |
| Novartis Investigative Site | Melbourne | Victoria | 3000 | Australia |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Singapore | 169610 | Singapore |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |