Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

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 blood, plasma and urine biomarkers of Fms activity.

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

Keywords

Solid Tumor PVNS Neoplasms PLX3397

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCLA
    Los Angeles California 90404 United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas Nevada 89169 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Plexxikon
ID
NCT01004861
Phase
Phase 1
Study Type
Interventional
Last Updated