Clinical trial NCT01499043: Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: CRPC
Prostate Cancer
Bone metastasis
Advanced Castration-Resistant Prostate Cancer (CRPC)
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Plexxikon
First posted: 2011-12-26
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells
timeFrame: See measure description for time frame.
Secondary outcomes:
measure: Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term
timeFrame: Assessed from first dose through at least 4 weeks after the last dose.
measure: Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade
timeFrame: Assessed from first dose through at least 4 weeks after the last dose.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
References: