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Also known as Nilotinib, Nilotinib 100mg
Nilotinib+ LDE225 · 1 trial · 1 indication
Determination of the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of nilotinib in combination with LDE225
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Nilotinib + LDE225 | DRUG | Nilotinib is an aminopyrimidine ATP-competitive inhibitor of the protein tyrosine kinaseactivity of BCR-ABL. |
Inclusion Criteria: 1. Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) or accelerated phase (AP)with resistance to at least one prior BCR-ABL targeting TKI 2. Documented chronic phase CML 3. Adequate end organ function 4. Female patients of childbearing potential must have a negati...
Nilotinib is used for Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Chronic Myelogenous Leukemia, Myelogenous Leukemia, Chronic, Gastrointestinal Stromal Tumor (GIST), Chronic Myeloid Leukemia, and Glioma. It is an investigational small molecule in Phase 3 clinical development for these oncology indications.
Nilotinib is a kinase inhibitor, belonging to the -tinib class of targeted therapies. It works by inhibiting specific kinases involved in cancer cell growth and survival, particularly those implicated in Philadelphia Chromosome Positive leukemias. The drug is being studied for its activity against these molecular targets in various oncology settings.
Nilotinib is developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of Nilotinib across multiple cancer indications, including chronic myeloid leukemia and gastrointestinal stromal tumors.
Nilotinib is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in multiple oncology indications, with a total of 10 clinical trials conducted, of which 9 are completed and 1 is active but not recruiting.
Nilotinib has been studied in several clinical trials. Notable ones include NCT01220648, a Phase 1 trial in pretreated Ph+ CML-CP patients; NCT01223898, a Phase 1 drug interaction study; NCT02253277, a Phase 1 combination trial with ruxolitinib; and NCT03906292, an active Phase 2 trial of frontline asciminib combination in chronic phase CML.
Yes, Nilotinib 300 mg and Nilotinib 100mg refer to different dosage strengths of the same drug, Nilotinib. These are alternative names used to specify the particular dose formulation being administered in clinical studies or prescriptions. The active pharmaceutical ingredient is identical across these dosage forms.