Safety Study of PLX108-01 in Patients With Solid Tumors
This study is currently recruiting participants.
Verified March 2013 by Plexxikon
Sponsor:
Plexxikon
Information provided by (Responsible Party):
Plexxikon
ClinicalTrials.gov Identifier:
NCT01004861
First received: October 28, 2009
Last updated: March 15, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
At This Time, All Cohorts Are Closed to Enrollment With the Exception of the Pigmented Villo-nodular Synovitis (PVNS) Cohort. |
Drug: PLX3397 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Plexxikon:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 95 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PLX3397 |
Drug: PLX3397
Capsules administered once or twice daily, continuous dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004861
Locations
| United States, Arizona | |
| TGen Clinical Research Service at Scottsdale Healthcare | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Cancer Care Coordinator 877-273-3713 | |
| Principal Investigator: Daniel D Von Hoff, MD | |
| Sub-Investigator: Raoul Tibes, MD | |
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Zev Wainberg, MD ZWainberg@mednet.ucla.edu | |
| Principal Investigator: Zev Wainberg, MD | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Muhammad Khan, MD 281-863-6538 muhammad.khan@mckesson.com | |
| Principal Investigator: Allen Cohn, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Eunice Kwak, MD 617-643-3415 ekwak@partners.org | |
| Principal Investigator: Eunice Kwak, MD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Sue Gotthardt, RN 617-632-9272 sgotthar@bidmc.harvard.edu | |
| Principal Investigator: Eunice Kwak, MD | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Andrew Wolanski, NP 617-632-6623 andrew_wolanski@dfci.harvard.edu | |
| Principal Investigator: Eunice Kwak, MD | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| Contact: Muhammad Khan, MD 281-863-6538 muhammad.khan@mckesson.com | |
| Principal Investigator: Fadi Braiteh, MD, CPI | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center (MSKCC) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Marietta Ezeike ezeokem@mskcc.org | |
| Principal Investigator: William Tap, MD | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates | Recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Contact: Susan Kilcoyne, RN susankilcoyne@pennoncology.com | |
| Principal Investigator: Arthur Staddon, MD | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Larisa Zifchak Larisa.Zifchak@uphs.upenn.edu | |
| Principal Investigator: Marcia Brose, MD, PhD | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Kelly Field kelly.field@fccc.edu | |
| Principal Investigator: Ranee Mehra, MD | |
| United States, Tennessee | |
| Vanderbilt-Ingram Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Wendy VerMeulen, RN 800-811-8480 wendy.vermeulen@vanderbilt.edu | |
| Contact: Lora Risley, RN 800-811-8480 | |
| Principal Investigator: Igor Puzanov, MD | |
| United States, Texas | |
| Texas Oncology, PA (North) | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Muhammad Khan, MD 281-863-6538 Muhammad.Khan@USOncology.com | |
| Principal Investigator: Carlos Becerra, MD | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Muhammad Khan, MD 281-863-6538 muhammad.khan@mckesson.com | |
| Principal Investigator: Paul Conkling, MD | |
| United States, Washington | |
| Evergreen Hematology & Oncology | Recruiting |
| Spokane, Washington, United States, 99218 | |
| Contact: Melanie Matson, RN 509-464-2873 Mmatson@evergreen4cure.com | |
| Principal Investigator: Stephen P Anthony, DO | |
Sponsors and Collaborators
Plexxikon
More Information
No publications provided
| Responsible Party: | Plexxikon |
| ClinicalTrials.gov Identifier: | NCT01004861 History of Changes |
| Other Study ID Numbers: | PLX108-01 |
| Study First Received: | October 28, 2009 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Plexxikon:
|
PVNS |
Additional relevant MeSH terms:
|
Synovitis Synovitis, Pigmented Villonodular Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013