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

NCT02449681 | Terminated Phase 2 DMC

• 1 other identifier: TH-CR-602
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 10

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.

Conditions

Metastatic Head-and-neck Squamous-cell Carcinoma

Keywords

squamous cell carcinoma; the head and neck; skin; TH-4000; Hypoxia; Tarloxotinib

Outcome Measures

Primary Outcomes (1)

• Number of participants with response rate as evaluated by RECIST criteria

  Approximately 12 months

Secondary Outcomes (9)

• 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)

  Up to 30 days after last dose

• Duration of response (DOR) calculated for all patients achieving an objective response

  Approximately 12 months

• Progression-free survival (PFS)

  Approximately 12 months

Other Outcomes (1)

• Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging

  Baseline

Study Arms (1)

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

TH-4000 (Tarloxotinib) DRUG

Also known as: Tarloxotinib

TH-4000 (Tarloxotinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Rain Oncology Inc: lead

Study Sites (10)

University of Southern California-Norris

Los Angeles, California, 90033, United States

Location

Stanford school of Medicine

Stanford, California, 94305, United States

Location

Georgetown Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Walter Reed National Military Cancer Center

Bethesda, Maryland, 20889, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt-Ingram Cancer Center (VICC)

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Peter MacCallum

East Melbourne, Victoria, 3002, Australia

Location

Related Publications (1)

• 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.

  PMID: 35435625 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Hypoxia

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Liu

  Georgetown University Hospital Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label single arm two-stage, phase-2 study

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 20, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 31, 2017
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

AU (2); US (8)