PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
- Conditions
- Castration Resistant Prostate Cancer (CRPC)
- Registration Number
- JPRN-jRCT2031230184
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 267
Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts:
Japan cohort
*Castration resistant prostate cancer that is resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)
Other inclusion criteria:
*Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
*Adequate organ function
*Prior Chemotherapy: no more than 2 previous regimens of chemotherapy
*Prior irradiation to >25% of the bone marrow.
*QTcF interval >480 msec at screening.
*Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
*Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
*Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
*Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers or inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method