Status:
TERMINATED
Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Plexxikon
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC. Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor ef...
Eligibility Criteria
Inclusion
- Histologically confirmed prostate cancer, currently with objective progressive disease.
- Castrate level of testosterone (\<50 ng/dL).
- Baseline circulating tumor cell (CTC) count ≥10/7.5 mL blood.
- Archival tumor tissue (unstained sections, paraffin block, or frozen tumor tissue) has been requisitioned for shipment to the central laboratory.
- Karnofsky performance status of 80-100.
- Adequate organ and marrow function.
Exclusion
- The subject has received:
- Any systemic chemotherapy (including investigational agents) within 4 weeks (with the exception of nitrosoureas/mitomycin C within 6 weeks), of the first dose of study treatment, OR
- Biological agents (antibodies, immune modulators, cytokines, or vaccines) within 6 weeks of the first dose of study treatment, OR
- Hormonal anticancer therapy (not including LHRH agonists or antagonists) within 2 weeks before the first dose of study treatment. Specific restrictions on prior hormonal and other anticancer treatments are detailed in inclusion criterion, OR
- Small-molecular kinase inhibitors or any other type of investigational agent within 4 weeks before the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is shorter.
- The subject has received drugs used to control loss of bone mass (e.g., bisphosphonates) within 4 weeks prior to the first dose of study treatment.
- The subject has symptomatic or uncontrolled brain metastasis or epidural disease requiring current treatment including steroids and anti-convulsants.
- The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \>450 ms at screening.
- The subject has uncontrolled or significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders such as symptomatic congestive heart failure (CHF), \*Uncontrolled hypertension
- Unstable angina pectoris, clinically-significant cardiac arrhythmias
- History of stroke (including transient ischemic attack \[TIA\] or other ischemic event) within 6 months of study treatment
- Myocardial infarction within 6 months of study treatment
- History of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion.
Key Trial Info
Start Date :
May 25 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01499043
Start Date
May 25 2012
End Date
March 11 2013
Last Update
March 4 2020
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065