PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients:
with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes refractory anemia with excess blasts (RAEB), RAEB in transformation (RAEB-T) or chronic myelomonocytic leukemia (CMML).
2. Patients with a relevant FLT3-ITD mutation or D835Y point mutation
3. Patients at least 18 years or older
4. Patients with WHO performance status of 0 to 2 with a life expectancy of at least 3 months
5. Patients must not be treated within 4 weeks after any prior therapy
6. Written informed consent obtained according to local guidelines
You may not be if
Patients meeting any of the following criteria during screening will be excluded from entry into the study:
1. Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously.
2. Female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control.
3. Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study.
4. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PKC412.
