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

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ClinicalTrials.gov Identifier: NCT02449681
Recruitment Status : Terminated (Lack of efficacy)
First Posted : May 20, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Threshold Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 12, 2015
First Posted Date  ICMJE May 20, 2015
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
Number of participants with response rate as evaluated by RECIST criteria [ Time Frame: Approximately 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02449681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 27, 2016)
Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging [ Time Frame: Baseline ]
Original Other Pre-specified Outcome Measures
 (submitted: May 15, 2015)
  • Hypoxic volume as measured by Photon Emission Tomography (PET) hypoxia imaging [ Time Frame: Baseline ]
  • Veristrat status [ Time Frame: Baseline and during Cycle 1 on Day 8 ]
  • Intratumoral CD8 concentration [ Time Frame: Baseline and during Cycle 1 on Day 8 ]
  • EGFR phosphorylation concentration [ Time Frame: Baseline and during Cycle 1 on Day 8 ]
 
Descriptive Information
Brief Title  ICMJE Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS
Official Title  ICMJE A Phase 2 Study of TH-4000 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Intervention  ICMJE Drug: TH-4000
Other Name: Tarloxotinib
Study Arms  ICMJE Experimental: TH-4000 (Tarloxotinib)
Intervention: Drug: TH-4000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: May 15, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02449681
Other Study ID Numbers  ICMJE TH-CR-602
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Threshold Pharmaceuticals
Study Sponsor  ICMJE Threshold Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Liu Georgetown University Hospital Cancer Center
Principal Investigator: Danny Rischin Peter MacCallum Cancer Centre, Australia
PRS Account Threshold Pharmaceuticals
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP