Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: PLX3397
Intervention description: Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRPC; Prostate Cancer; Bone metastasis; Advanced Castration-Resistant Prostate Cancer (CRPC)

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 effects that PLX3397 has on the the subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.