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History of Changes for Study: NCT03515538
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (PREVLAR)
Latest version (submitted January 7, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 2, 2018 None (earliest Version on record)
2 May 3, 2018 Outcome Measures and Study Status
3 June 7, 2018 Study Status
4 July 26, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 October 17, 2018 Contacts/Locations and Study Status
6 December 5, 2018 Contacts/Locations, Sponsor/Collaborators, Study Status and Study Description
7 December 17, 2018 Contacts/Locations and Study Status
8 May 29, 2019 Contacts/Locations and Study Status
9 October 9, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 November 22, 2019 Study Status
11 July 21, 2020 Study Status
12 January 7, 2021 Recruitment Status and Study Status
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Study NCT03515538
Submitted Date:  May 2, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: PR-001
Brief Title: Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (PREVLAR)
Official Title: A Phase 2a Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: May 2018
Primary Completion: June 2019 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: April 18, 2018
First Submitted that
Met QC Criteria:
May 2, 2018
First Posted: May 3, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 2, 2018
Last Update Posted: May 3, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: EpicentRx, Inc.
Responsible Party: Sponsor
Collaborators: Drais Pharmaceuticals, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length 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 in arms 1, 2 and 3 will also receive RRx-001 on different schedules.
Detailed Description: The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there are no approved therapies to treat or prevent it.
Open or close this module Conditions
Conditions: Oral Mucositis
Keywords: head and neck cancer
squamous
neck cancer
oral cancer
mucositis
sores
mouth
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: RRx-001 Pre-Treatment plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin
Drug: RRx-001
RRx-001 for injection
Drug: Cisplatin for injection
Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients
Radiation: Radiation Therapy
Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Experimental: RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration
Drug: RRx-001
RRx-001 for injection
Drug: Cisplatin for injection
Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients
Radiation: Radiation Therapy
Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Experimental: RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration
Drug: RRx-001
RRx-001 for injection
Drug: Cisplatin for injection
Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients
Radiation: Radiation Therapy
Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Active Comparator: Standard of Care
No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7).
Drug: Cisplatin for injection
Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients
Radiation: Radiation Therapy
Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Duration of Severe Oral Mucositis (SOM)
[ Time Frame: up to one year ]

Duration in days of severe oral mucositis (SOM). Defined as oral mucositis grade 3 or 4 (WHO Mucositis Grading Scale).
Secondary Outcome Measures:
1. Time to onset of SOM
[ Time Frame: up to one year ]

Time to onset of SOM defined as time (in days) from randomization to the first observed SOM.
2. Incidence of SOM
[ Time Frame: up to one year ]

Duration (in days) of ulcerative oral mucositis defined as the proportion of patients experiencing oral mucositis during the randomized treatment period
3. Duration and incidence of ulcerative OM
[ Time Frame: up to one year ]

Incidence of ulcerative oral mucositis defined as the proportion of patients experiencing ulcerative oral mucositis during the randomized treatment period.
4. Patient-reported pain
[ Time Frame: up to one year ]

Patient-report mouth and throat soreness graded on a discrete scale from 0 to 4 (0 = no soreness, . . . , 4 = extreme soreness).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity and oropharynx Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criterion #3 below are eligible for the trial
  2. Treatment planned to include standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) with concomitant radiation delivered as a continuous course of IMRT with 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 > 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.
  3. ECOG performance status ≤ 2.
  4. Participants must have adequate organ and marrow function as defined below:

    A. Absolute neutrophil count (ANC) >1,500 / mm3 B. Platelets > 100,000 / mm3 C. Hemoglobin ≥ 9.0 g/dL

  5. Adequate renal and liver function as indicated by:

    A. Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) B. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) C. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN D. Alkaline phosphatase ≤ 2.5 x ULN

  6. Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test for patients with cancers of the oropharynx, base of tongue, or unknown primary.
  7. Age 18 years or older
  8. 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.
  9. Ability to understand and sign a written informed consent document.
  10. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 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
  11. 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.

Exclusion Criteria:

  1. Prior radiation to the head and neck
  2. Tumor of the lips, nasopharynx, hypopharynx, larynx, or salivary glands
  3. Patients with simultaneous primaries or bilateral tumors
  4. Metastatic disease (M1) Stage IV
  5. 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
  6. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at study entry
  7. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal diet
  8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason
  9. 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)
  10. Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema).
  11. Pregnant or nursing
  12. Untreated active oral or dental infection, including severe tooth decay (caries)
  13. Known allergies or intolerance to cisplatin and similar platinum-containing compounds
  14. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
  15. Receipt of unapproved or off-label medication within 30 days prior to start of study treatment
  16. Sjogren syndrome
Open or close this module Contacts/Locations
Central Contact Person: Scott Caroen
Telephone: 415-715-7786
Email: scaroen@EpicentRx.com
Study Officials: Bryan Oronsky, MD PhD
Study Director
EpicentRx, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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