Safety Study of PLX108-01 in Patients With Solid Tumors

This study is currently recruiting participants.

Verified March 2013 by Plexxikon

Sponsor:

Information provided by (Responsible Party):

Plexxikon

ClinicalTrials.gov Identifier:

NCT01004861

First received: October 28, 2009

Last updated: March 15, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 28, 2009
Last Updated Date	March 15, 2013
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 28, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01004861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 28, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of PLX108-01 in Patients With Solid Tumors
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	At This Time, All Cohorts Are Closed to Enrollment With the Exception of the Pigmented Villo-nodular Synovitis (PVNS) Cohort.
Intervention ^ICMJE	Drug: PLX3397 Capsules administered once or twice daily, continuous dosing
Study Arm (s)	Experimental: PLX3397 Intervention: Drug: PLX3397
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	95
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01004861
Other Study ID Numbers ^ICMJE	PLX108-01
Has Data Monitoring Committee	No
Responsible Party	Plexxikon
Study Sponsor ^ICMJE	Plexxikon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Plexxikon
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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