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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
At This Time, All Cohorts Are Closed to Enrollment With the Exception of the Pigmented Villo-nodular Synovitis (PVNS) Cohort.

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, ECGs and clinical laboratory tests

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PLX108-01

NCT ID:

NCT01004861

Start Date:

September 2009

Completion Date:

August 2013

Related Keywords:

  • At This Time, All Cohorts Are Closed to Enrollment With the Exception of the Pigmented Villo-nodular Synovitis (PVNS) Cohort.
  • PVNS
  • Synovitis
  • Synovitis, Pigmented Villonodular

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Rocky Mountain Cancer CentersThornton, Colorado  80260
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCLALos Angeles, California  90095
Evergreen Hematology & OncologySpokane, Washington  99218
TGEN Clinical Research Service at Scottsdale HealthcareScottsdale, Arizona  85258
Memorial Sloan-Kettering Cancer Center (MSKCC)New York, New York  10065
Vanderbilt-Ingram Medical CenterNashville, Tennessee  37232
Texas Oncology, PA (North)Dallas, Texas  75246