Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)

Daiichi Sankyo

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: PLX3397

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499043

PLX108-06

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

PLX3397

Experimental group

Description:

Participants will take daily oral dose of PLX3397 for 28 day cycles. Participants will continue to take PLX3397 until disease progression or toxicity.

Treatment:

Drug: PLX3397