Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponatinib · 2 trials · 11 indications
The primary endpoint is the proportion of patients who are in CHR at 6 months, calculated on the total number of patients who have been enroled and have received at least one dose of the first drug (prednisone).
Defined as the occurrence of any protocol-defined toxicities occurring after dosing and up to and including Day 28, except those toxicities with a clear alternative explanation.
Defined as complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) as assessed by conventional cytogenetics or fluorescence in situ hybridization (FISH).
Assessed by polymerase chain reaction (PCR).
Assessed by conventional cytogenetics, FISH, or PCR.
According to Lugano criteria based on computed tomography (CT) or magnetic resonance imaging (MRI) (or positron emission tomography \[PET\]).
Defined as the percentage of participants having CR or PR, as determined by investigator assessment of radiographic disease per tumors per RANO for central nervous system (CNS) tumors or Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumors based on CT or MRI (or PET).
| Arm | Type | Description |
|---|---|---|
| Ponatinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ponatinib | DRUG | Treatment: Patients will receive daily oral administration of Ponatinib at a dose of 45 mg/day for 6 weeks (defined as one course) for 8 courses, same dose and schedule, for a total of 48 weeks. Each patient will be followed for the subsequent 24 months, every 3 month, providing survival information and monitoring serious adverse event. Each patient should be treated for a minimum of 6 weeks. Patients must be discontinued from the trial in the event of myocardial infarction or stroke, or for development or progression of arterial disease necessitating revascularization. Once a complete hematologic response has been achieved, with a platelet count ≥ 50x109/L, patients can be treated with aspirin and/or a statin as clinically indicated, at investigator discretion. |
Inclusion Criteria: 1. To be classified as having Ph+ ALL, patients must have \>20% blasts in bone marrow at the time of diagnosis and no prior history of CML. 2. Patients with previously untreated Ph+ and/or BCR/ABL + ALL: * age ≥ 60 years old or * age ≥ 18 years old, but unfit for program ...
Ponatinib is an investigational small molecule being studied for use in Philadelphia Positive Acute Myeloid Leukemia. It is also being evaluated in clinical trials for other leukemias, lymphomas, and solid tumors. Ponatinib is in Phase 1 development and is not yet approved by the FDA.
Ponatinib is a kinase inhibitor, belonging to the -tinib class of drugs. It is being studied for its activity against BCR-ABL positive leukemias, including Philadelphia Positive Acute Myeloid Leukemia. The drug is designed to inhibit certain kinases involved in cancer cell growth.
Ponatinib is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. Incyte is conducting clinical trials to evaluate the safety and efficacy of Ponatinib in various cancer indications.
Ponatinib is currently in Phase 1 clinical development. It is being studied in a Phase 1 trial for pediatric patients with recurrent or refractory leukemias, lymphomas, or solid tumors. Ponatinib is an investigational drug and has not received FDA approval.
Ponatinib is being studied in a Phase 1 clinical trial with the identifier NCT03934372. This trial is recruiting pediatric patients with acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, lymphoma, and solid tumors. The trial is enrolling participants in multiple European countries.
Ponatinib is also known by the brand name Iclusig. In clinical trials, it is referred to as ponatinib, and it is being investigated for use in Philadelphia chromosome positive leukemias. The drug is a kinase inhibitor developed by Incyte Corporation.