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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02449681




Registration number
NCT02449681
Ethics application status
Date submitted
12/05/2015
Date registered
20/05/2015
Date last updated
27/02/2017

Titles & IDs
Public title
Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS
Scientific title
A Phase 2 Study of TH-4000 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Secondary ID [1] 0 0
TH-CR-602
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TH-4000

Experimental: TH-4000 (Tarloxotinib) -


Treatment: Drugs: TH-4000


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with response rate as evaluated by RECIST criteria
Timepoint [1] 0 0
Approximately 12 months
Secondary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to 30 days after last dose
Secondary outcome [2] 0 0
Type of adverse events (AEs)
Timepoint [2] 0 0
Up to 30 days after last dose
Secondary outcome [3] 0 0
Severity of adverse events (AEs)
Timepoint [3] 0 0
Up to 30 days after last dose
Secondary outcome [4] 0 0
Duration of response (DOR) calculated for all patients achieving an objective response
Timepoint [4] 0 0
Approximately 12 months
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Approximately 12 months
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Approximately 12 months
Secondary outcome [7] 0 0
Maximum plasma concentration of TH4000 (prodrug) and TH-4000E (TKI effector)
Timepoint [7] 0 0
Cycle 1 Day 1 predose and up to 24 hours postdose
Secondary outcome [8] 0 0
Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector)
Timepoint [8] 0 0
Cycle 1 Day 1 predose and up to 24 hours postdose
Secondary outcome [9] 0 0
QTc Interval
Timepoint [9] 0 0
Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Peter MacCallum - East Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Threshold Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02449681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Liu
Address 0 0
Georgetown University Hospital Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02449681