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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000282-12 | EudraCT Number |
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The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nilotinib + LDE225 | Experimental | The planned dose of nilotinib 400 mg b.i.d (twice a day) was selected for the combination as this is the dose approved for the treatment of the patient population that will be included in the present study. The starting dose for LDE225 chosen for the current study is 400 mg once daily(q.d.). The maximum dose of LDE225 that will be tested in combination with nilotinib is 800 mg once dail.y |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib + LDE225 | Drug | Nilotinib is an aminopyrimidine ATP-competitive inhibitor of the protein tyrosine kinaseactivity of BCR-ABL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate and category of dose limiting toxicities (DLTs) during the first two cycles of therapy | Determination of the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of nilotinib in combination with LDE225 | 56 days (2 treatment cycles at 28 days each) |
| Measure | Description | Time Frame |
|---|---|---|
| No of participants with Adverse drug reactions and serious adverse drug reactions, changes in hematology and blood chemistry values, assessments of physical examinations, vital signs and electrocardiograms | Assessment of the safety and tolerability profile of nilotinib in combination with LDE225 | 336 days (12 treatment cycles) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Reuslts for CAMN107Y2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| Plasma concentration and basic pharmacokinetics (PK) parameters (as Cmax, Tmax, AUC) |
Assessment of the PK characteristics of nilotinib administered in combination with LDE225 |
| 50 days |
| Major molecular response (MMR) rates at 3, 6 and 12 months | Determination of the kinetics of major molecular response | 336 days (12 treatment cycles) |
| Complete molecular response (CMR) rates at 3, 6 and 12 months | Determination of the kinetics of complete molecular response | 336 days (12 treatment cycles) |
| Major cytogenic response (MCyR) rates by 3, 6 and 12 months | Determination of major cytogenetic response rates | 336 days (12 treatment cycles) |
| Complete cytogenic response (CCyR) rates by 3, 6 and 12 months | Determination of complete cytogenetic response rates | 336 days (12 treatment cycles) |
| Marseille |
| 13273 |
| France |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
| C561435 | sonidegib |
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