PLATFORMPACAN1001
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
Leukemia, Myeloid, Acute
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Neoplasms
Solid Tumor, Adult
Prostatic Neoplasms, Castration-Resistant
The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
- Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study
- Satisfy all ISA specific inclusion criteria
- Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA
- Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA
Exclusion Criteria:
- Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject’s participation in the study
- Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA
- Meets any exclusion criteria within the pertinent ISA
Linear Clinical Research, Perth, Western Australia, 6009
Contact +61 08 6382 5100
cancertrialshaem4@linear.org.au
Janssen Research & Development, LLC
Phase 1
PLATFORMPACAN1001
NCT06788509
