Phase 2 platform study of combination therapy with pimitespib in patients with malignant tumors
- Conditions
- CRPC cohortMetastatic castration-resistant prostate cancer
- Registration Number
- JPRN-jRCT2031230263
- Lead Sponsor
- Sato Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 32
Castration-resistant prostate cancer (CRPC) cohort
- Provided written informed consent
- Histologically confirmed prostatic cancer
- Had the treatment with novel hormone agent (NHA) as the most recent previous treatment
- CRPC or metastatic hormone-sensitive prostate cancer previously treated with one NHA
- Documented disease progression during treatment with NHA as the most recent therapy
- Naive to chemotherapy (cytotoxic anticancer drugs, etc) and Ra-223 as treatment for metastatic CRPC
- Have at least one evaluable lesion per RECIST v1.1 and/or bone metastatic disease detected by bone scintigraphy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
CRPC cohort
- A serious illness or medical condition
- Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study
- QTcF interval >470 msec at baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CRPC cohort<br><Feasibility part><br>Dose limiting toxicity (DLT) during Cycle 1.<br><br><Expansion part><br>Radiographic progression-free survival (rPFS) based on RECIST v1.1 and PCWG3 by the independent radiological review
- Secondary Outcome Measures
Name Time Method Adverse event, Adverse drug reaction, Laboratory abnormalities