Safety Study of PLX108-01 in Patients With Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01004861 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 30, 2009
Last Update Posted
: February 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor | Drug: PLX3397 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | September 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: PLX3397 |
Drug: PLX3397
Capsules administered once or twice daily, continuous dosing
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- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 and older
- Solid tumors refractory to standard therapy
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004861
United States, Arizona | |
TGen Clinical Research Service at Scottsdale Healthcare | |
Scottsdale, Arizona, United States, 85258 | |
United States, California | |
UCLA | |
Los Angeles, California, United States, 90404 | |
United States, Colorado | |
Rocky Mountain Cancer Centers | |
Denver, Colorado, United States, 80218 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Nevada | |
Comprehensive Cancer Centers of Nevada | |
Las Vegas, Nevada, United States, 89169 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center (MSKCC) | |
New York, New York, United States, 10065 | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | |
Philadelphia, Pennsylvania, United States, 19106 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
Vanderbilt-Ingram Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Texas Oncology, PA (North) | |
Dallas, Texas, United States, 75246 | |
United States, Virginia | |
Virginia Oncology Associates | |
Norfolk, Virginia, United States, 23502 | |
United States, Washington | |
Evergreen Hematology & Oncology | |
Spokane, Washington, United States, 99218 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Plexxikon |
ClinicalTrials.gov Identifier: | NCT01004861 History of Changes |
Other Study ID Numbers: |
PLX108-01 |
First Posted: | October 30, 2009 Key Record Dates |
Last Update Posted: | February 2, 2018 |
Last Verified: | January 2018 |
Keywords provided by Plexxikon:
PVNS |