Safety Study of PLX108-01 in Patients With Solid Tumors - Full Text View

Sponsor:	Plexxikon
Information provided by (Responsible Party):	Plexxikon
ClinicalTrials.gov Identifier:	NCT01004861

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 plasma and urine biomarkers of Fms activity.

Condition	Intervention	Phase
Solid Tumors Mucoepidermal Carcinoma (MEC) of the Salivary Gland Pigmented Villo-nodular Synovitis (PVNS) Gastrointestinal Stromal Tumors (GIST) Anaplastic Thyroid Carcinoma (ATC) Solid Tumors With Documented Malignant Pleural or Peritoneal Effusions	Drug: PLX3397	Phase I

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:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases

U.S. FDA Resources

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: 1 year ] [ 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: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	95
Study Start Date:	September 2009
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (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 pgmented villo-nodular snovitis (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

Contacts and Locations

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
Sub-Investigator: Raoul Tibes, MD
United States, California
UCLA	Recruiting
Los Angeles, California, United States, 90095
Contact: Zev Wainberg, MD ZWainberg@mednet.ucla.edu
Principal Investigator: Zev Wainberg, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eunice Kwak, MD 617-643-3415 ekwak@partners.org
Principal Investigator: Eunice Kwak, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sue Gotthardt, RN 617-632-9272 sgotthar@bidmc.harvard.edu
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, Tennessee
Vanderbilt-Ingram Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Wendy VerMeulen, RN 800-811-8480 wendy.vermeulen@vanderbilt.edu
Contact: Lora Risley, RN 800-811-8480
Principal Investigator: Igor Puzanov, MD
United States, Washington
Evergreen Hematology & Oncology	Recruiting
Spokane, Washington, United States, 99218
Contact: Melanie Matson, RN 509-464-2873 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:	November 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Plexxikon:

GIST
ATC
PVNS
Effusions
Head and neck tumors

Additional relevant MeSH terms:

Carcinoma
Thyroid Neoplasms
Synovitis
Synovitis, Pigmented Villonodular
Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site

Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Joint Diseases
Musculoskeletal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012