Chronic Myeloid Leukemia in Chronic Phase
Conditions
Interventions
Product Name: Ponatinib
Product Code: AP24534
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ponatinib
CAS Number: 943319-70-8
Current Sponsor code: AP24534 HCI
Other descriptive name: P
Sponsors
ARIAD Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients =18 years old 2. CP-CML within 6 months of diagnosis 3. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 5. Adequate hepatic function as defined in the protocol 6. Adequate renal function as defined in the protocol 7. Adequate pancreatic function as defined in the protocol 8. For females of childbearing potential, a negative pregnancy test must be documented prior to randomization 9. Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment 10. Provide written informed consent 11. Willingness and ability to comply with scheduled visits and study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 368 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: 1. Received prior imatinib therapy 2. Received prior dasatinib therapy 3. Received prior nilotinib therapy 4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea 5. Major surgery within 28 days prior to initiating therapy 6. History of bleeding disorder unrelated to CML 7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis 8. History of alcohol abuse 9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL) 10. Clinically significant uncontrolled or active cardiovascular disease 11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control. 12. Taking medications that are known to be associated with Torsades de Pointes (Appendix A) 13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection 14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history 15. Pregnant or breastfeeding 16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs 17. Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ) 18. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days);Secondary Objective: - To compare, according to treatment with ponatinib versus imatinib, MMR rate at 5 years - To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABLIS), in patients administered ponatinib versus those administered imatinib - To compare, according to treatment with ponatinib versus imatinib, the complete cytogenetic response (CCyR) rate at 12 months - To compare, according to treatment with ponatinib versus imatinib, progression-free survival and overall survival Other secondary and exploratory study objectives as listed in the protocol;Primary end point(s): MMR rate at 12 months (1 month or cycle = 28 days);Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: 1 MMR rate at 5 years 2 <10% BCR-ABLIS rate at 3 months 3 CCyR rate at 12 months 4 Progression-free survival 5 Overall survival Other Secondary Endpoints as listed in the protocol;Timepoint(s) of evaluation of this end point: 1 MMR rate at 5 years 2 <10% BCR-ABLIS rate at 3 months 3 CCyR rate at 12 months | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactBao Le
ARIAD Pharmaceuticals, Inc
Outcome results
None listed