Safety Study of PLX108-01 in Patients With Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Plexxikon
Sponsor:
Information provided by (Responsible Party):
Plexxikon
ClinicalTrials.gov Identifier:
NCT01004861
First received: October 28, 2009
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.


Condition Intervention Phase
At This Time, All Cohorts Are Closed to Enrollment With the Exception of the Pigmented Villo-nodular Synovitis (PVNS) Cohort.
Drug: PLX3397
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients With Advanced, Incurable, Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology

Resource links provided by NLM:


Further study details as provided by Plexxikon:

Primary Outcome Measures:
  • Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, ECGs and clinical laboratory tests [ Time Frame: till end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK profile: PLX3397 PK parameters including, but not limited to, maximum observed concentration (Cmax), area under the plasma concentration-time curve and half-life [ Time Frame: till end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLX3397 Drug: PLX3397
Capsules administered once or twice daily, continuous dosing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and older
  • Solid tumors refractory to standard therapy
  • For the Extension cohorts, patients must have measurable disease by RECIST criteria and meet the following disease-specific criteria:

    • For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.
    • For pigmented villo-nodular synovitis (PVNS), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months.
    • For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry.
    • For anaplastic thyroid cancer (ATC), patients must have histologically or cytologically diagnosed advanced ATC.
    • For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.
  • ECOG performance status 0 or 1
  • Life expectancy >= 3 months
  • Adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

  • Specific anti-cancer therapy within 3 weeks of study start
  • Uncontrolled intercurrent illness
  • Refractory nausea or vomiting, or malabsorption
  • Mean QTc >= 450 msec (for males) or QTc >= 470 msec (for females)
  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: NCT01004861

Locations
United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Cancer Care Coordinator    877-273-3713      
Principal Investigator: Daniel D Von Hoff, MD         
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90404
Contact: Zev Wainberg, MD       ZWainberg@mednet.ucla.edu   
Principal Investigator: Zev Wainberg, MD         
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Muhammad Khan, MD    281-863-6538    muhammad.khan@usoncology.com   
Principal Investigator: Allen Cohn, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eunice Kwak, MD    617-724-0695    ekwak@partners.org   
Principal Investigator: Eunice Kwak, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew Wolanski, NP    617-632-6623    andrew_wolanski@dfci.harvard.edu   
Principal Investigator: Eunice Kwak, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Muhammad Khan, MD    281-863-6538    muhammad.khan@usoncology.com   
Principal Investigator: Fadi Braiteh, MD, CPI         
United States, New York
Memorial Sloan-Kettering Cancer Center (MSKCC) Recruiting
New York, New York, United States, 10065
Contact: Olivia McKennan       mckennao@mskcc.org   
Principal Investigator: William Tap, MD         
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Jennifer King, RN       jenniferking@pennoncology.com   
Principal Investigator: Arthur Staddon, MD         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Kelly Field       kelly.field@fccc.edu   
Principal Investigator: Ranee Mehra, MD         
United States, Tennessee
Vanderbilt-Ingram Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Wendy VerMeulen, RN    800-811-8480    wendy.vermeulen@vanderbilt.edu   
Principal Investigator: Igor Puzanov, MD         
United States, Texas
Texas Oncology, PA (North) Recruiting
Dallas, Texas, United States, 75246
Contact: Muhammad Khan, MD    281-863-6538    Muhammad.Khan@USOncology.com   
Principal Investigator: Carlos Becerra, MD         
United States, Virginia
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Muhammad Khan, MD    281-863-6538    muhammad.khan@usoncology.com   
Principal Investigator: Paul Conkling, MD         
United States, Washington
Evergreen Hematology & Oncology Recruiting
Spokane, Washington, United States, 99218
Contact: Melanie Matson, RN    509-893-809    Mmatson@evergreen4cure.com   
Principal Investigator: Stephen P Anthony, DO         
Sponsors and Collaborators
Plexxikon
  More Information

No publications provided

Responsible Party: Plexxikon
ClinicalTrials.gov Identifier: NCT01004861     History of Changes
Other Study ID Numbers: PLX108-01
Study First Received: October 28, 2009
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Plexxikon:
PVNS

Additional relevant MeSH terms:
Synovitis
Synovitis, Pigmented Villonodular
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 23, 2014