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

NCT01499043 | Terminated Phase 2 Results

• 1 other identifier: PLX108-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

CRPC; Prostate Cancer; Bone metastasis; Advanced Castration-Resistant Prostate Cancer (CRPC)

Outcome Measures

Primary Outcomes (1)

• Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells

  Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay) CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up. Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication was to continue until the progression had been confirmed.

  See measure description for time frame.

Secondary Outcomes (2)

• Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term

  Assessed from first dose through at least 4 weeks after the last dose.

• Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade

  Assessed from first dose through at least 4 weeks after the last dose.

Study Arms (1)

PLX3397

EXPERIMENTAL

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

Drug: PLX3397

Interventions

PLX3397 DRUG

Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.

PLX3397

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Plexxikon: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pexidartinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

This study did not meet its planned enrollment goal of 20 participants by the end of 2012. Therefore, enrollment was terminated and efficacy was not evaluated; only the safety results are reported.

Results Point of Contact

• Title: Medical Director
• Organization: Daiichi Sankyo Inc.

CTRinfo@dsi.com

908-992-6400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: May 25, 2012
• Primary Completion: March 11, 2013
• Study Completion: March 11, 2013
• Last Updated: March 4, 2020
• Results First Posted: October 18, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (2)