Study for Treatment of Patients With Recurrent or Metasta... | NCT02449681

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of efficacy

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 31, 2017Actual

First Submitted Date

May 12, 2015

First Submission Date that Met QC Criteria

May 15, 2015

First Posted Date

May 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 8, 2022

Certification/Extension First Submitted that Passed QC Review

Jan 9, 2023

Certification/Extension First Posted Date

Jan 12, 2023Actual

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TH-4000 (Tarloxotinib)	Experimental	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.	Drug: TH-4000 (Tarloxotinib)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TH-4000 (Tarloxotinib)	Drug		TH-4000 (Tarloxotinib)	Tarloxotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with response rate as evaluated by RECIST criteria		Approximately 12 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)		Up to 30 days after last dose
Type of adverse events (AEs)		Up to 30 days after last dose
Severity of adverse events (AEs)

Other Outcomes

Measure	Description	Time Frame
Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging		Baseline

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stephen Liu	Georgetown University Hospital Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California-Norris		Los Angeles	California	90033	United States
Stanford school of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35435625	Derived	McLean LS, Morris TA, Gramza A, Liu S, Khan SA, Colevas AD, Pearce T, Rischin D. A phase II study of tarloxotinib (a hypoxia activated prodrug of a pan-erb tyrosine kinase inhibitor) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. Invest New Drugs. 2022 Aug;40(4):782-788. doi: 10.1007/s10637-022-01230-w. Epub 2022 Apr 18.

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D002294	Carcinoma, Squamous Cell
D000860	Hypoxia

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D018307	Neoplasms, Squamous Cell
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms