Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

Metastatic Head-and-neck Squamous-cell Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02449681
• Other study ID #: TH-CR-602
• Status: Terminated
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: January 2023
• Source: Rain Oncology Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

An open label, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 31, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Metastatic Head-and-neck Squamous-cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• TH-4000 (Tarloxotinib)

Locations

Country	Name	City	State
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Peter MacCallum	East Melbourne	Victoria
United States	Walter Reed National Military Cancer Center	Bethesda	Maryland
United States	University of Chicago	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	University of Southern California-Norris	Los Angeles	California
United States	Vanderbilt-Ingram Cancer Center (VICC)	Nashville	Tennessee
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Stanford school of Medicine	Stanford	California
United States	Georgetown Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Rain Oncology Inc

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging		Baseline
Primary	Number of participants with response rate as evaluated by RECIST criteria		Approximately 12 months
Secondary	Incidence of adverse events (AEs)		Up to 30 days after last dose
Secondary	Type of adverse events (AEs)		Up to 30 days after last dose
Secondary	Severity of adverse events (AEs)		Up to 30 days after last dose
Secondary	Duration of response (DOR) calculated for all patients achieving an objective response		Approximately 12 months
Secondary	Progression-free survival (PFS)		Approximately 12 months
Secondary	Overall Survival (OS)		Approximately 12 months
Secondary	Maximum plasma concentration of TH-4000 (prodrug) and TH-4000E (TKI effector)		Cycle 1 Day 1 predose and up to 24 hours postdose
Secondary	Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector)		Cycle 1 Day 1 predose and up to 24 hours postdose
Secondary	QTc Interval		Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination