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Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS

This study has been terminated.
(Lack of efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02449681
First Posted: May 20, 2015
Last Update Posted: February 27, 2017
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.
Information provided by (Responsible Party):
Threshold Pharmaceuticals
  Purpose
This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

Condition Intervention Phase
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin Drug: TH-4000 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of TH-4000 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

Resource links provided by NLM:


Further study details as provided by Threshold Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants with response rate as evaluated by RECIST criteria [ Time Frame: Approximately 12 months ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ]
  • Type of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ]
  • Severity of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ]
  • Duration of response (DOR) calculated for all patients achieving an objective response [ Time Frame: Approximately 12 months ]
  • Progression-free survival (PFS) [ Time Frame: Approximately 12 months ]
  • Overall Survival (OS) [ Time Frame: Approximately 12 months ]
  • Maximum plasma concentration of TH4000 (prodrug) and TH-4000E (TKI effector) [ Time Frame: Cycle 1 Day 1 predose and up to 24 hours postdose ]
  • Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector) [ Time Frame: Cycle 1 Day 1 predose and up to 24 hours postdose ]
  • QTc Interval [ Time Frame: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination ]

Other Outcome Measures:
  • Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging [ Time Frame: Baseline ]

Estimated Enrollment: 60
Study Start Date: August 2015
Study Completion Date: January 31, 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TH-4000 (Tarloxotinib) Drug: TH-4000
Other Name: Tarloxotinib

Detailed Description:

An open label, parallel-group, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 (Tarloxotinib) will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

  Eligibility

Information from the National Library of Medicine

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
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Confirmed squamous cell carcinoma 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

Exclusion Criteria:

  • Received prior EGFR TKI therapy for recurrent or metastatic SCC (e.g., oral EGFR TKIs such as erlotinib, gefitinib, or afatinib)
  • Family history of long QTc syndrome
  • Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication
  • 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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02449681


Locations
United States, California
University of Southern California-Norris
Los Angeles, California, United States, 90033
Stanford school of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
Georgetown Medical Center
Washington, District of Columbia, United States, 20007
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Walter Reed National Military Cancer Center
Bethesda, Maryland, United States, 20889
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States, 37232
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Peter MacCallum
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Threshold Pharmaceuticals
Investigators
Principal Investigator: Stephen Liu Georgetown University Hospital Cancer Center
Principal Investigator: Danny Rischin Peter MacCallum Cancer Centre, Australia
  More Information

Responsible Party: Threshold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02449681     History of Changes
Other Study ID Numbers: TH-CR-602
First Submitted: May 12, 2015
First Posted: May 20, 2015
Last Update Posted: February 27, 2017
Last Verified: November 2016

Keywords provided by Threshold Pharmaceuticals:
squamous cell carcinoma
the head and neck
skin
TH-4000
Hypoxia
Tarloxotinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site