A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Janssen (J&J Innovative Medicine)

Status and phase: Invitation-only; Phase 1

Conditions: Solid Tumor, Adult; Neoplasms; Metastatic Castration-resistant Prostate Cancer (mCRPC); Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: JNJ-54179060; Drug: JNJ-70218902; Drug: JNJ-74856665; Drug: JNJ-67856633; Drug: JNJ-64619178; Drug: JNJ-75348780; Drug: JNJ-64264681

Study type: Interventional

Funder types: Industry

Identifiers

NCT06788509

PLATFORMPACAN1001 (Other Identifier)

2024-515457-21-00 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Long Term Safety Assessment (Platform Study)

Other group

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) 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.

Treatment:

Drug: JNJ-64264681

Drug: JNJ-64619178

Drug: JNJ-75348780

Drug: JNJ-70218902

Drug: JNJ-74856665

Drug: JNJ-54179060

Drug: JNJ-67856633