Continued Treatment and Safety Monitoring for People With Certain Cancers
Follows people with blood cancers and solid tumors who continue study drugs long term.
Plain-language title generated from the registry record
Registry title: A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
Key facts
- Where
- Copenhagen Oe and Odense C, DenmarkSee the 2 sites
- Phase
- Phase 1
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
- Odense University HospitalOdense C, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06788509EU 2024-515457-21-00
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring
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: 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: 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.