Trial record 15 of 27 for:    Threshold

Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Threshold Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Threshold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02449681
First received: May 12, 2015
Last updated: May 19, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Drug: TH-4000
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of TH-4000 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

Resource links provided by NLM:


Further study details as provided by Threshold Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants with response rate as evaluated by RECIST criteria [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]
  • Type of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]
  • Severity of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]
  • Duration of response (DOR) calculated for all patients achieving an objective response [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of TH4000 (prodrug) and TH-4000E (TKI effector) [ Time Frame: Cycle 1 Day 1 predose and up to 24 hours postdose ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector) [ Time Frame: Cycle 1 Day 1 predose and up to 24 hours postdose ] [ Designated as safety issue: No ]
  • QTc Interval [ Time Frame: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Hypoxic volume as measured by Photon Emission Tomography (PET) hypoxia imaging [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Veristrat status [ Time Frame: Baseline and during Cycle 1 on Day 8 ] [ Designated as safety issue: No ]
  • Intratumoral CD8 concentration [ Time Frame: Baseline and during Cycle 1 on Day 8 ] [ Designated as safety issue: No ]
  • EGFR phosphorylation concentration [ Time Frame: Baseline and during Cycle 1 on Day 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2015
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TH-4000 Drug: TH-4000

Detailed Description:

An open label, parallel-group, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02449681

Contacts
Contact: Debby Brown dbrown@thresholdpharm.com
Contact: Tillman Pearce, MD tpearce@thresholdpharm.com

Locations
United States, California
United States, California Not yet recruiting
Los Angeles, California, United States, 90033
United States, District of Columbia
United States, District of Columbia Not yet recruiting
Washington, District of Columbia, United States, 20007
United States, Maryland
United States, Maryland Not yet recruiting
Bethesda, Maryland, United States, 20889
United States, North Carolina
United States, North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
United States, Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
United States, Texas Not yet recruiting
Dallas, Texas, United States, 75390
Australia, New South Wales
Australia, Sydney Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Australia, Victoria Not yet recruiting
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Threshold Pharmaceuticals
Investigators
Principal Investigator: Stephen Liu Georgetown University Hospital Cancer Center
Principal Investigator: Danny Rischin Peter MacCallum Cancer Centre, Australia
  More Information

No publications provided

Responsible Party: Threshold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02449681     History of Changes
Other Study ID Numbers: TH-CR-602
Study First Received: May 12, 2015
Last Updated: May 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Threshold Pharmaceuticals:
squamous cell carcinoma
the head and neck
skin
TH-4000
Hypoxia

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on May 21, 2015