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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499043
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):

Brief Summary:

The main objective of this study is to evaluate the effects on the body that PLX3397 on male subjects with CRPC.

Secondary objectives include evaluating the safety and tolerability of PLX3397 and the antitumor effects that PLX3397 has on the the subjects.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: PLX3397 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of PLX3397 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients With Bone Metastasis and High Circulating Tumor Cell (CTC)Counts
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: PLX3397
Subjects will take daily oral dose of PLX3397 for 28 day cycles. Subjects will continue to take PLX3397 until disease progression or toxicity.
Drug: PLX3397
Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.

Primary Outcome Measures :
  1. Efficacy-Biomarker Profiling [ Time Frame: 1 year ]
    Circulating tumor cells (CTCs) will be measured every 4 weeks.

Secondary Outcome Measures :
  1. Safety-Subject incidence of adverse events [ Time Frame: 1 year ]

    Subject incidence of adverse events will be summarized. Adverse events will be tallied for overall frequency, worst reported severity, and relationship to study drug for each preferred term per subject. Serious adverse events will be similarly summarized.

    Clinically significant changes in vital signs, ECGs and clinical laboratory tests (hematology and chemistry) will be summarized by changes from baseline to scheduled time points using descriptive statistics.

  2. Efficacy-Treatment Outcomes [ Time Frame: 1 year ]

    Subjects will be monitored for disease progression using the following outcomes:

    • Prostate Serum Antigen (PSA). PSA will be measured every 8 weeks
    • Soft Tissue Disease. Target lesions will be measured via CT scan every 8 weeks
    • Bone Disease. Assessed via radionuclide bone scans and whole body MRIs every 8 weeks.
    • Time to Progression (TTP). Measured from start of treatment until progression.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499043

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators

Responsible Party: Plexxikon Identifier: NCT01499043     History of Changes
Other Study ID Numbers: PLX108-06
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: March 2015

Keywords provided by Plexxikon:
Prostate Cancer
Bone metastasis
Advanced Castration-Resistant Prostate Cancer (CRPC)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases