Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
NCT ID: NCT02449681
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2015-08-31
2017-01-31
Brief Summary
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Detailed Description
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Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TH-4000 (Tarloxotinib)
TH-4000 150 mg/m2 will be administered by IV infusion over 60 minutes on Days 1, 8, 15 and 22 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
TH-4000 (Tarloxotinib)
Interventions
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TH-4000 (Tarloxotinib)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
* For patients with oropharyngeal cancer, p16 status is known or can be determined
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Acceptable laboratory results as indicated by protocol
* Acceptable cardiac function as indicated by protocol
* Family history of long QTc syndrome
* Symptomatic central nervous system (CNS) lesions, or CNS lesions that require therapy
* Radiation therapy within 2 weeks prior to the first dose of study medication
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
* Concurrent active malignancy requiring systemic treatment
* Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
* Pregnant or breast-feeding
Exclusion Criteria
* Family history of long corrected QT interval (QTc) syndrome
18 Years
ALL
No
Sponsors
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Rain Oncology Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Liu
Role: PRINCIPAL_INVESTIGATOR
Georgetown University Hospital Cancer Center
Locations
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University of Southern California-Norris
Los Angeles, California, United States
Stanford school of Medicine
Stanford, California, United States
Georgetown Medical Center
Washington D.C., District of Columbia, United States
University of Chicago
Chicago, Illinois, United States
Walter Reed National Military Cancer Center
Bethesda, Maryland, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum
East Melbourne, Victoria, Australia
Countries
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References
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McLean LS, Morris TA, Gramza A, Liu S, Khan SA, Colevas AD, Pearce T, Rischin D. A phase II study of tarloxotinib (a hypoxia activated prodrug of a pan-erb tyrosine kinase inhibitor) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. Invest New Drugs. 2022 Aug;40(4):782-788. doi: 10.1007/s10637-022-01230-w. Epub 2022 Apr 18.
Other Identifiers
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TH-CR-602
Identifier Type: -
Identifier Source: org_study_id
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