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

October 28, 2009
September 9, 2013
September 2009
December 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01004861 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Safety Study of PLX108-01 in Patients With Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
At This Time, All Cohorts Are Closed to Enrollment With the Exception of the Pigmented Villo-nodular Synovitis (PVNS) Cohort.
Drug: PLX3397
Capsules administered once or twice daily, continuous dosing
Experimental: PLX3397
Intervention: Drug: PLX3397
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2015
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
United States
 
NCT01004861
PLX108-01
No
Plexxikon
Plexxikon
Not Provided
Not Provided
Plexxikon
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP