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A study of JNJ-80038114 in participants with advanced stage prostate cancer

Phase 1
Conditions
Cancer
Prostate cancer
Registration Number
ISRCTN16457874
Lead Sponsor
Janssen-Cilag International NV
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
Male
Target Recruitment
49
Inclusion Criteria

1. 18 years and older
2. Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
3. Measurable or evaluable disease
4. At least 1 prior treatment for mCRPC
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ functions as defined by certain laboratory values
7. Must sign an informed consent form (ICF)
8. Participants must agree to use a highly effective form of birth control as guided by the study doctor

Exclusion Criteria

1. Concurrent anticancer therapy
2. Severe or long-lasting side effects related to prior anticancer therapy
3. Known allergies to JNJ-80038114 or its excipients
4. Brain metastasis or known seizure history
5. Significant infections or lung, heart or other medical conditions

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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