Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of the Effects of GC4419 on Severe Oral Mucositis in Patients Receiving Cisplatin + IMRT for Locally Advanced Non-Metastatic SCC of the Oral Cavity/Oropharynx

Details

GT-201 is a randomized, double-blind, placebo-controlled, multi-center study conducted in the U.S. to evaluate GC4419 administered IV for the reduction of incidence, duration, and severity of radiation induced oral mucositis in patients receiving cisplatin plus intensity-modulated radiation therapy for post-operative, or definitive treatment of locally advanced, non-metastatic squamous cell carcinoma of the head and neck, limited to the oral cavity or oropharynx. Patients will be randomized equally to 1 of 3 treatment arms:

Arm A: 30 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).

Arm B: 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).

Arm C: Placebo daily (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).

Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy.

All patients will be assessed twice weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 8 weeks, or until oral mucositis resolves to ≤ Grade 1.

Approximately 200 total to ensure that roughly 60 patients per arm receive study drug and complete requirements for primary endpoint analysis, which is defined as patients receiving a minimum cumulative dose of 60 Gy.

Keywords

Radiation Induced Oral Mucositissquamous cell carcinoma of the head and neckoral cavityoropharynxintensity-modulated radiation therapychemotherapyoral mucositissuperoxide dismutaseradioprotectionMucositisStomatitisLow Dose GC4419: 30mg/dayHigh Dose GC4419: 90mg/day

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck, defined as SCC of the oral cavity or oropharynx that will be treated with cisplatin plus concurrent IMRT Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criteria #2 and #3 below are eligible for the trial.
  2. Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
  3. Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (80-100 mg/m2 for 3 doses) or weekly (30-40 mg/m2 for 6-7 doses). The decision on which chemotherapy regimen to use in combination with IMRT and GC4419 will be at the discretion of the investigator.
  4. Age 18 years or older
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. Adequate hematologic function as indicated by:
  7. Absolute neutrophil counts (ANC) ≥ 1,500/mm3
  8. Hemoglobin (Hgb) ≥ 9.0 g/dL
  9. Platelet count ≥ 100,000/mm3
  10. Adequate renal and liver function as indicated by:
  11. Serum creatinine acceptable for treatment with cisplatin per institutional guidelines
  12. Total bilirubin ≤ 1.5 x upper-normal limit (ULN)
  13. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  14. Alkaline phosphatase ≤ 2.5 x ULN
  15. Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test
  16. Serum pregnancy test negative for females of childbearing potential
  17. . Males and females must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the last dose of GC4419
  18. . Properly obtained written informed consent

You CAN'T join if...

  1. Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
  2. Metastatic disease (Stage IV C)
  3. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemotolerance)
  4. Prior induction chemotherapy
  5. Receiving any approved or investigational anti-cancer agent other than those provided for in this study
  6. Participation in another clinical trial or use of another investigational agent within 30 days of study entry
  7. Requirement for significantly modified diet (liquids and/or solids) due to compromised oral/pharyngeal function at baseline
  8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason
  9. Malignant tumors other than HNC within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator
  10. . Active infectious disease excluding oral candidiasis
  11. . Presence of oral mucositis (WHO Score ≥ Grade 1) at study entry
  12. . Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
  13. . Female patients who are pregnant or breastfeeding
  14. . Known allergies or intolerance to cisplatin and similar platinum-containing compounds
  15. . 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

Locations

  • UC Irvine Chao Family Comprehensive Cancer Center
    OrangeCalifornia92868United States
  • VA Long Beach Healthcare System
    Long BeachCalifornia90822United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Galera Therapeutics, Inc.
ID
NCT02508389
Phase
Phase 2
Study Type
Interventional
Last Updated