A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Galera Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01921426
First received: August 8, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following:

  • Effect on the incidence and severity of radiation induced oral mucositis;
  • Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy;
  • Total concentrations of GC4419 that can be achieved in the blood;
  • Changes in proteins and genetics associated with oral mucositis;
  • Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth);
  • Observe changes in genetic and molecular markers of oral mucositis;
  • Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients;
  • Assess the overall quality of life in study patients with oral mucositis.

Condition Intervention Phase
Squamous Cell Carcinoma of the Oral Cavity
Squamous Cell Carcinoma of the Oropharynx
Drug: GC4419
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase 1 Dose Escalation Study of GC4419 in Combination With Radiation and Chemotherapy for Squamous Cell Cancers of the Head and Neck.

Resource links provided by NLM:


Further study details as provided by Galera Therapeutics, Inc.:

Primary Outcome Measures:
  • Frequency and Severity of Adverse Events Resulting from GC4419 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    GC4419 will be evaluated to determine safety, tolerability, and the maximum tolerated dose of GC4419 that can be administered to patients with squamous cell cancer of the head and neck who are receiving concurrent radiation (50-70 Gy, administered daily x 5 [M-F], in 2.0-2.2 Gy fractions) and chemotherapy (cisplatin, 80-100mg/m2, q3 weeks). Patients will receive 14 doses of GC4419, which correspond to the first 14 doses of radiation. Dose limiting toxicity will be evaluated through the first 21 days on study.


Secondary Outcome Measures:
  • Rate and Extent of Exposure to GC4419 (Pharmacokinetic Profile) [ Time Frame: 18 Days ] [ Designated as safety issue: Yes ]
    Determine the pharmacokinetic profile, including the extent and rate of exposure (e.g., maximum concentration, total exposure, half life, time to maximum concentration, accumulation, etc.) to GC4419, as well as GC4419 kinetics (e.g., half-life, in patients with squamous cell carcinoma of the head and neck receiving GC4419 when administered in combination with standard chemoradiation.

  • Oral Mucositis [ Time Frame: 49 Days ] [ Designated as safety issue: Yes ]
    Determine the incidence, severity, time to first onset and duration of oral mucositis in patients with squamous cell carcinoma of the head and neck receiving GC4419 when administered in combination with standard chemoradiation.

  • Antitumor Effect [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
    Preliminarily assess the tumor response to standard chemoradiation when administered in conjunction with GC4419 at approximately 1 year following completion of chemoradiation.


Other Outcome Measures:
  • Pharmacodynamic Profile [ Time Frame: 49 Days ] [ Designated as safety issue: No ]
    Determine the pharmacodynamic profile of GC4419 in patients with squamous cell carcinoma of the head and neck receiving GC4419 when administered in combination with standard chemoradiation by observing the changes in proteins and genetic markers associated oral mucositis.


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GC4419
Open label, dose escalation study of GC4419 administered in 14 doses, corresponding to the first 14 doses of radiation therapy. Each dose will be given intravenously over 60 minutes. The possible doses which may be tested are: 15mg, 30mg, 50mg, 75mg, 112mg, and 170mg.
Drug: GC4419

  Eligibility

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

Inclusion Criteria:

  • Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN), defined as SCC of the oral cavity or oropharynx, that will be treated with standard cisplatin and Intensity-Modulated Radiation Therapy (IMRT)
  • Males or females aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate bone marrow, liver and kidney function
  • Negative serum pregnancy test for females of childbearing potential
  • Properly obtained written informed consent

Exclusion Criteria:

  • Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, salivary glands or unknown primary tumor
  • Metastatic disease (Stage IV C)
  • Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or
  • Receiving any agent classified as an antioxidant
  • History of malignant tumors other than SCCHN within the last 5 years, except non-melanoma skin cancer or curatively excised in situ cervical carcinoma
  • Active infectious disease excluding oral candidiasis
  • Presence of oral mucositis at study entry
  • Chronic immunosuppression
  • Known history of HIV or active hepatitis B/C )
  • Prior history of hearing impairment
  • Use of investigational agent within 30 days of study entry
  • Known allergies or intolerance to cisplatin and similar platinum-containing compounds
  • Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
  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: NCT01921426

Locations
United States, Connecticut
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Jennifer Long, ANP-BC    203-852-2996    jennifer.long@norwalkhealth.org   
Principal Investigator: Pardip Pathare, MD         
United States, Florida
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Robin S. Stewart, RN PhD OCN    863-904-1877    robin.stewart@lrmc.com   
Principal Investigator: Madhavi Venigalla, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt    319-353-7143    sandy-vollstedt@uiowa.edu   
Principal Investigator: John Buatti, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Lacey Johnson    314-362-0208    ljohnson@dom.wustl.edu   
Principal Investigator: Douglas Adkins, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Amy Filler-Katz, RN BSN    402-552-2790    afillerkatz@unmc.edu   
Principal Investigator: Weining Zhen, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Therese Smudzin, BS    585-275-7848    therese_smudzin@urmc.rochester.edu   
Principal Investigator: Yuhchyau Chen, MD PhD         
United States, Ohio
Summa Health System- Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Lynn Kaplan, RN OCN    330-375-6121    kaplanlm@summahealth.org   
Principal Investigator: Charles Kunos, MD PhD         
United States, Pennsylvania
St. Luke's Cancer Center Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Stacie Dancho, RN, CURN, OCN    484-503-4150    Stacie.Dancho@sluhn.org   
Principal Investigator: Sanjiv Agarwala, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Susan Hebda, BS, CCRC    412-359-4046    shebda@wpahs.org   
Principal Investigator: Larisa Greenberg, MD         
United States, Texas
Cancer Specialists of South Texas, P.A. Recruiting
Corpus Christie, Texas, United States, 78412
Contact: Katrina Powell, CCRC    361-993-3456 ext 140    kpowell@corpuschristicancer.com   
Principal Investigator: Aftab Mahmood, MD         
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
Study Director: Jon T. Holmlund, MD Galera Therapeutics, Inc.
Principal Investigator: Madhavi Venigalla, MD Lakeland Regional Cancer Center
Principal Investigator: Weining Zhen, MD University of Nebraska
Principal Investigator: Douglas Adkins, MD Washington University School of Medicine
Principal Investigator: Pardip Pathare, MD Norwalk Hospital
Principal Investigator: Sanjiv Agarwala, MD St. Luke's Cancer Center
Principal Investigator: Charles Kunos, MD, PhD Summa Health System- Cooper Cancer Center
Principal Investigator: Yuhchyau Chen, MD, PhD University of Rochester
Principal Investigator: John Buatti, MD University of Iowa
Principal Investigator: Aftab Mahmood, MD Cancer Specialists of South Texas, P.A.
Principal Investigator: Larisa Greenberg, MD West Penn Allegheny Health System
  More Information

No publications provided

Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01921426     History of Changes
Other Study ID Numbers: GT-001
Study First Received: August 8, 2013
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Galera Therapeutics, Inc.:
Squamous Cell Carcinoma of the Head and Neck
Oral Cavity
Oropharynx
Radiation
Chemotherapy
Cisplatin
Oral Mucositis
Superoxide Dismutase

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014