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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02449681




Registration number
NCT02449681
Ethics application status
Date submitted
12/05/2015
Date registered
20/05/2015
Date last updated
12/01/2023

Titles & IDs
Public title
Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Scientific title
A Phase 2 Study of Tarloxotinib (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:
Metastatic Head-and-neck Squamous-cell Carcinoma 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 (Tarloxotinib)

Experimental: 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.


Treatment: Drugs: TH-4000 (Tarloxotinib)
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 TH-4000 (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 (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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
therapy for recurrent or metastatic Squamous Cell Carcinoma (e.g., oral EGFR TKIs such
as erlotinib, gefitinib, or afatinib)

- Family history of long corrected QT interval (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
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2017
Sample size
Target
Accrual to date
Final
30
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
Rain Oncology Inc
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, 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/ct2/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/ct2/show/NCT02449681