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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Plexxikon
ClinicalTrials.gov Identifier:
NCT01499043
First received: December 20, 2011
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: PLX3397
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Plexxikon:

Primary Outcome Measures:
  • Efficacy-Biomarker Profiling [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Circulating tumor cells (CTCs) will be measured every 4 weeks.


Secondary Outcome Measures:
  • Safety-Subject incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.


  • Efficacy-Treatment Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.


Enrollment: 6
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499043

Locations
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
Plexxikon
  More Information

No publications provided

Responsible Party: Plexxikon
ClinicalTrials.gov Identifier: NCT01499043     History of Changes
Other Study ID Numbers: PLX108-06
Study First Received: December 20, 2011
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014