A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are acceptable. HPV determination must be made for all patients.

• Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of \> 55 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.

• ECOG performance status ≤ 2.

• Participants must have adequate organ and marrow function as defined below:

• • Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2. Platelets ≥ 75,000 / mm3 3. Hemoglobin ≥ 9.0 g/dL

• Adequate renal and liver function as indicated by:

• • Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) 2. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 4. Alkaline phosphatase ≤ 2.5 x ULN

• Human papilloma virus (HPV) status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016, Martens 2017). HPV status at baseline optional for oral cavity tumors.

• Age 18 years or older

• Patient must consent to the access, review, and analysis of previous medical and cancer history, including imaging data, by the sponsor or a third party nominated by the sponsor.

• Ability and willingness to understand and sign a written informed consent document.

⁃ Women of childbearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

⁃ Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

‣ Has not undergone a hysterectomy or bilateral oophorectomy; or

‣ Has not been postmenopausal for at least 12 consecutive months

⁃ Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate.

Locations
United States
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
The University of Arizona Cancer Center
RECRUITING
Tucson
Florida
Miami Cancer Institute
RECRUITING
Miami
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Indiana
Parkview Cancer Institute
RECRUITING
Fort Wayne
Louisiana
Willis Knighton Cancer Center
RECRUITING
Shreveport
Maryland
Sandra and Malcolm Berman Cancer Institute
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
East Carolina University School of Medicine
RECRUITING
Greenville
Nevada
Renown Regional Medical Center
RECRUITING
Reno
Ohio
The Ohio State University James Cancer Hospital & Solove Research Institute
RECRUITING
Columbus
Tennessee
Ballad Health
RECRUITING
Johnson City
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Scott Caroen
scaroen@epicentrx.com
8589476635
Backup
Jeannie Williams
jwilliams@epicentrx.com
8589476635
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 216
Treatments
Experimental: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period
Experimental: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period.
Placebo_comparator: Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period.
Related Therapeutic Areas
Sponsors
Leads: EpicentRx, Inc.

This content was sourced from clinicaltrials.gov