Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01456676 | Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy | PHASE1 | COMPLETED | 11 | — | — | Jan 1, 2012 | Feb 1, 2014 | Dec 9, 2020 | 7 | Canada, France +3 |
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...