Safety Study of PLX108-01 in Patients With Solid Tumors
NCT ID: NCT01004861
Last Updated: 2022-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
132 participants
INTERVENTIONAL
2009-10-01
2018-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PLX3397
PLX3397
Capsules administered once or twice daily, continuous dosing
Interventions
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PLX3397
Capsules administered once or twice daily, continuous dosing
Eligibility Criteria
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Inclusion Criteria
* 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.
* Eastern Cooperative Oncology Group performance status 0 or 1
* Life expectancy \>= 3 months
* Adequate hepatic, renal, and bone marrow function
Exclusion Criteria
* Uncontrolled intercurrent illness
* Refractory nausea or vomiting, or malabsorption
* Mean corrected QT interval (QTc) \>= 450 msec (for males) or QTc \>= 470 msec (for females)
18 Years
ALL
No
Sponsors
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Plexxikon
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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HonorHealth
Scottsdale, Arizona, United States
UCLA
Los Angeles, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Medical Center
Nashville, Tennessee, United States
Texas Oncology, PA (North)
Dallas, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Evergreen Hematology & Oncology
Spokane, Washington, United States
Countries
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References
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Tap WD, Singh AS, Anthony SP, Sterba M, Zhang C, Healey JH, Chmielowski B, Cohn AL, Shapiro GI, Keedy VL, Wainberg ZA, Puzanov I, Cote GM, Wagner AJ, Braiteh F, Sherman E, Hsu HH, Peterfy C, Gelhorn HL, Ye X, Severson P, West BL, Lin PS, Tong-Starksen S. Results from Phase I Extension Study Assessing Pexidartinib Treatment in Six Cohorts with Solid Tumors including TGCT, and Abnormal CSF1 Transcripts in TGCT. Clin Cancer Res. 2022 Jan 15;28(2):298-307. doi: 10.1158/1078-0432.CCR-21-2007. Epub 2021 Oct 29.
Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.
Tap WD, Wainberg ZA, Anthony SP, Ibrahim PN, Zhang C, Healey JH, Chmielowski B, Staddon AP, Cohn AL, Shapiro GI, Keedy VL, Singh AS, Puzanov I, Kwak EL, Wagner AJ, Von Hoff DD, Weiss GJ, Ramanathan RK, Zhang J, Habets G, Zhang Y, Burton EA, Visor G, Sanftner L, Severson P, Nguyen H, Kim MJ, Marimuthu A, Tsang G, Shellooe R, Gee C, West BL, Hirth P, Nolop K, van de Rijn M, Hsu HH, Peterfy C, Lin PS, Tong-Starksen S, Bollag G. Structure-Guided Blockade of CSF1R Kinase in Tenosynovial Giant-Cell Tumor. N Engl J Med. 2015 Jul 30;373(5):428-37. doi: 10.1056/NEJMoa1411366.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PLX108-01
Identifier Type: -
Identifier Source: org_study_id
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