Clinical trial · Interventional
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring
NCT06788509CI-TRIAL-00124329enrolling by invitationPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Leukemia, Myeloid, Acute | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-54179060 | Drug | — | UNRESOLVED |
| JNJ-64264681 | Drug | — | UNRESOLVED |
| JNJ-64619178 | Drug | — | UNRESOLVED |
| JNJ-67856633 | Drug | — | UNRESOLVED |
| JNJ-70218902 | Drug | — | UNRESOLVED |
| JNJ-74856665 | Drug | — | UNRESOLVED |
| JNJ-75348780 | Drug | — | UNRESOLVED |
| JNJ-80948543 | Drug | — | UNRESOLVED |
| JNJ-87801493 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Long Term Safety Assessment (Platform Study)
- description
- The platform rollover study provides continued long-term access to study treatment(s) (JNJ-64264681; JNJ-67856633 (safimaltib); JNJ-54179060 (ibrutinib); JNJ-75348780; JNJ-74856665; JNJ-64619178; JNJ-70218902; JNJ-80948543; JNJ-87801493) for participants currently receiving the active study treatment in parent studies and deriving benefit from it. Eligible participants in parent study will rollover to this platform study which will be adapted into Intervention Specific Appendix (ISA) within the platform study. Participants will initiate the platform study under the relevant ISA, and will continue to receive study treatment at the dose they received in parent study.
- interventionNames
- Drug: JNJ-75348780
- Drug: JNJ-67856633
- Drug: JNJ-54179060
- Drug: JNJ-64264681
- Drug: JNJ-74856665
- Drug: JNJ-70218902
- Drug: JNJ-64619178
- Drug: JNJ-80948543
- Drug: JNJ-87801493
Primary outcomes (1)
- measure
- Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.