xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966194</url>
    </required_header>
    <id_info>
      <org_study_id>K-01</org_study_id>
      <nct_id>NCT05966194</nct_id>
    </id_info>
    <brief_title>Efficacy Study of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers</brief_title>
    <acronym>KEVLARx</acronym>
    <official_title>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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>EpicentRx, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>EpicentRx, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and&#xD;
        radiation treatment, reduces the incidence of severe oral mucositis in patients with head and&#xD;
        neck cancers. All patients in this study will receive 7 weeks of standard of care radiation&#xD;
        therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or&#xD;
        placebo before start of standard of care treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The standard treatment for head and neck cancer currently includes a chemotherapy drug called&#xD;
        cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a&#xD;
        machine that precisely targets the tumor. One common and unfortunate side effect of treatment&#xD;
        with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of&#xD;
        the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral&#xD;
        mucositis may lead to severe pain, nutritional problems and dehydration from an inability to&#xD;
        eat and drink, an increased risk of infection from bacteria and fungus and delay or&#xD;
        discontinuation of treatment and 2) because there is only one approved therapy to treat or&#xD;
        prevent it.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>The incidence of SOM defined as the proportion of patients with any WHO Grade &gt;= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Severe Oral Mucositis through 60 Gy of the Radiation Treatment Plan</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>incidence of SOM defined as the proportion of patients with any WHO Grade &gt;= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through 60 Gy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Duration of SOM (through the last day of radiation therapy, DoSOM). Its principal analysis employs the probability of being in response (PBIR), an intuitive concept based on the realization that the duration of response which is quantified as the area under the curve delimited by the duration of exposure (x axis) and the response probability (y axis).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Severe Oral Mucositis (SOM) through 60 Gy</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Duration of SOM (through 60 Gy, DoSOM) is compared between RRx-001 arms and Placebo using a two-sided log-rank test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to onset of Sever Oral Mucositis (ttSOM)</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Time onset to SOM (ttSOM) is defined as the time interval measured from the start of the observation period to the first time SOM is observed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of dysphagia</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Incidence and severity of dysphagia will be analyzed similarly to the primary efficacy endpoint.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative radiation dose to onset of SOM</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Cumulative radiation dose to onset of SOM is compared between RRx-001 arms and placebo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of grade 4 oral mucositis</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Incidence of grade 4 oral mucositis through 60 Gy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Narcotic use through resolution of SOM</measure>
      <time_frame>Estimated up to 18 Months</time_frame>
      <description>Narcotic use through resolution of SOM will be analyzed similarly to the cumulative radiation dose</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Oral Mucositis</condition>
    <arm_group>
      <arm_group_label>RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Pre-Treatment + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RRx-001</intervention_name>
      <description>RRx-001 for injection (4 mg or 8 mg)</description>
      <arm_group_label>RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_label>RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Intensity Modulated Radiation Therapy (IMRT)</intervention_name>
      <description>Intensity Modulated Radiation Therapy of up to 72 Gy</description>
      <arm_group_label>Placebo Pre-Treatment + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_label>RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_label>RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin for injection 100 mg/m2</intervention_name>
      <description>Cisplatin for injection 100 mg/m2</description>
      <arm_group_label>Placebo Pre-Treatment + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_label>RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
      <arm_group_label>RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity&#xD;
               or oropharynx Note: Patients with primary cancers that are presumed to be of&#xD;
               oropharyngeal origin may be included if they meet radiation field dosing criteria as&#xD;
               specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are&#xD;
               acceptable. HPV determination must be made for all patients.&#xD;
  &#xD;
            2. Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to&#xD;
               2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or&#xD;
               adjuvant chemotherapy. Planned radiation treatment fields must include at least two&#xD;
               oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned&#xD;
               to receive a total of &gt; 55 Gy. Patients who have had prior surgery are eligible,&#xD;
               provided they have fully recovered from surgery, and patients who may have surgery in&#xD;
               the future are eligible.&#xD;
  &#xD;
            3. ECOG performance status ≤ 2.&#xD;
  &#xD;
            4. Participants must have adequate organ and marrow function as defined below:&#xD;
  &#xD;
                 -  Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2. Platelets ≥ 75,000 / mm3 3.&#xD;
                    Hemoglobin ≥ 9.0 g/dL 5. Adequate renal and liver function as indicated by:&#xD;
  &#xD;
                 -  Serum creatinine acceptable for treatment with cisplatin per institutional&#xD;
                    guidelines) 2. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) 3. Aspartate&#xD;
                    aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 4. Alkaline&#xD;
                    phosphatase ≤ 2.5 x ULN 6. Human papilloma virus (HPV) status in tumor must be&#xD;
                    documented using tumor immunohistochemistry for HPV-p16 or other accepted test&#xD;
                    (such as such as in situ hybridization) for patients with cancers of the&#xD;
                    oropharynx or base of tongue (Rooper et al, 2016, Martens 2017).&#xD;
  &#xD;
            5. Age 18 years or older&#xD;
  &#xD;
            6. Patient must consent to the access, review, and analysis of previous medical and&#xD;
               cancer history, including imaging data, by the sponsor or a third party nominated by&#xD;
               the sponsor. 9. Ability and willingness to understand and sign a written informed&#xD;
               consent document.&#xD;
  &#xD;
            7. Women of childbearing potential and men with partners of child-bearing potential must&#xD;
               agree to use adequate contraception (hormonal or barrier method of birth control)&#xD;
               prior to study entry, for the duration of study participation, and for 90 days&#xD;
               following completion of therapy.&#xD;
  &#xD;
          Note: A woman of child-bearing potential is any female (regardless of sexual orientation,&#xD;
          having undergone a tubal ligation, or remaining celibate by choice) who meets the following&#xD;
          criteria:&#xD;
  &#xD;
            -  Has not undergone a hysterectomy or bilateral oophorectomy; or&#xD;
  &#xD;
            -  Has not been postmenopausal for at least 12 consecutive months 11. Adequate visual&#xD;
               access to permit examination of the following oral cavity sites: lips, buccal mucosa,&#xD;
               floor of mouth, ventral and lateral tongue, and soft palate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior radiotherapy to the head and neck region.&#xD;
  &#xD;
            2. Prior induction chemotherapy.&#xD;
  &#xD;
            3. Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.&#xD;
  &#xD;
            4. Patients with simultaneous primaries&#xD;
  &#xD;
            5. Stage IV, M1 (distant metastasis)&#xD;
  &#xD;
            6. Prior or current use of approved or investigational anticancer agent other than those&#xD;
               provided in this study.&#xD;
  &#xD;
            7. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity&#xD;
               Criteria, version 5.0) or inability to eat a normal (solid) diet&#xD;
  &#xD;
            8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition&#xD;
               for any reason or prophylactic insertion of gastrostomy tube with dependency on tube&#xD;
               feeding at baseline.&#xD;
  &#xD;
            9. Current use of analgesics (prescription and over the counter such as pregabalin,&#xD;
               gabapentin, skeletal muscle relaxants, benzodiazepines, sedative/hypnotics,&#xD;
               anxiolytics, oral analgesics, NSAIDs and opioids) are prohibited&#xD;
  &#xD;
           10. Malignant tumors other than squamous cell carcinoma of the head and neck within last 5&#xD;
               years, unless treated definitively and with low risk of recurrence in the judgment of&#xD;
               the treating investigator.&#xD;
  &#xD;
           11. Active infectious disease excluding oral candidiasis.&#xD;
  &#xD;
           12. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at&#xD;
               baseline.&#xD;
  &#xD;
           13. Untreated active oral or dental infection&#xD;
  &#xD;
           14. Known history of human immunodeficiency virus or active hepatitis B or C.&#xD;
  &#xD;
           15. Any significant medical diseases or conditions, as assessed by the investigators and&#xD;
               sponsor that would substantially increase the medical risks of participating in this&#xD;
               study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial&#xD;
               infarction within 6 months of study, severe chronic pulmonary disease or active&#xD;
               uncontrolled infection, uncontrolled or clinically relevant pulmonary edema)&#xD;
  &#xD;
           16. Pregnant or nursing.&#xD;
  &#xD;
           17. Known allergies or intolerance to cisplatin or other platinum-containing compounds.&#xD;
  &#xD;
           18. Sjogren syndrome&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Meaghan Stirn</last_name>
      <role>Study Director</role>
      <affiliation>EpicentRx, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Scott Caroen</last_name>
      <phone>8589476635</phone>
      <email>scaroen@epicentrx.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meaghan Stirn</last_name>
      <phone>8589476635</phone>
      <email>mstirn@epicentrx.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Bonomi M, Blakaj DM, Kabarriti R, Colvett K, Takiar V, Biagioli M, Bar-Ad V, Goyal S, Muzyka B, Niermann K, Abrouk N, Oronsky B, Reid T, Caroen S, Sonis S, Sher DJ. PREVLAR: Phase 2a Randomized Trial to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Head and Neck Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):551-559. doi: 10.1016/j.ijrobp.2022.12.031. Epub 2023 Jan 14.</citation>
      <PMID>36646388</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Head and Neck Cancer</keyword>
    <keyword>Neck cancer</keyword>
    <keyword>Oral cancer</keyword>
    <keyword>Mucositis</keyword>
    <keyword>Squamous cell carcinoma (SCC)</keyword>
    <keyword>HPV</keyword>
    <keyword>Oropharynx</keyword>
    <keyword>Oral cavity</keyword>
    <keyword>IMRT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mucositis</mesh_term>
      <mesh_term>Stomatitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cisplatin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966194
  org study id: K-01
  nct id: NCT05966194
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  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 is only one approved therapy to treat or
        prevent it.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
  time frame: Estimated up to 18 Months
  description: The incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT
  measure: Incidence of Severe Oral Mucositis through 60 Gy of the Radiation Treatment Plan
  time frame: Estimated up to 18 Months
  description: incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through 60 Gy
  measure: Duration of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
  time frame: Estimated up to 18 Months
  description: Duration of SOM (through the last day of radiation therapy, DoSOM). Its principal analysis employs the probability of being in response (PBIR), an intuitive concept based on the realization that the duration of response which is quantified as the area under the curve delimited by the duration of exposure (x axis) and the response probability (y axis).
  measure: Duration of Severe Oral Mucositis (SOM) through 60 Gy
  time frame: Estimated up to 18 Months
  description: Duration of SOM (through 60 Gy, DoSOM) is compared between RRx-001 arms and Placebo using a two-sided log-rank test.
  measure: Time to onset of Sever Oral Mucositis (ttSOM)
  time frame: Estimated up to 18 Months
  description: Time onset to SOM (ttSOM) is defined as the time interval measured from the start of the observation period to the first time SOM is observed.
  measure: Incidence and severity of dysphagia
  time frame: Estimated up to 18 Months
  description: Incidence and severity of dysphagia will be analyzed similarly to the primary efficacy endpoint.
  measure: Cumulative radiation dose to onset of SOM
  time frame: Estimated up to 18 Months
  description: Cumulative radiation dose to onset of SOM is compared between RRx-001 arms and placebo
  measure: Incidence of grade 4 oral mucositis
  time frame: Estimated up to 18 Months
  description: Incidence of grade 4 oral mucositis through 60 Gy
  measure: Narcotic use through resolution of SOM
  time frame: Estimated up to 18 Months
  description: Narcotic use through resolution of SOM will be analyzed similarly to the cumulative radiation dose
  arm group label: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
  arm group type: Experimental
  description: 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
  arm group label: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
  arm group type: Experimental
  description: 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.
  arm group label: Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
  arm group type: Placebo Comparator
  description: 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.
  intervention type: Drug
  intervention name: RRx-001
  description: RRx-001 for injection (4 mg or 8 mg)
  arm group label: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
  arm group label: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
  intervention type: Radiation
  intervention name: Intensity Modulated Radiation Therapy (IMRT)
  description: Intensity Modulated Radiation Therapy of up to 72 Gy
  arm group label: Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
  arm group label: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
  arm group label: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
  intervention type: Drug
  intervention name: Cisplatin for injection 100 mg/m2
  description: Cisplatin for injection 100 mg/m2
  arm group label: Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
  arm group label: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
  arm group label: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meaghan Stirn
  role: Study Director
  affiliation: EpicentRx, Inc.
  last name: Scott Caroen
  phone: 8589476635
  email: scaroen@epicentrx.com
  last name: Meaghan Stirn
  phone: 8589476635
  email: mstirn@epicentrx.com
  citation: Bonomi M, Blakaj DM, Kabarriti R, Colvett K, Takiar V, Biagioli M, Bar-Ad V, Goyal S, Muzyka B, Niermann K, Abrouk N, Oronsky B, Reid T, Caroen S, Sonis S, Sher DJ. PREVLAR: Phase 2a Randomized Trial to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Head and Neck Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):551-559. doi: 10.1016/j.ijrobp.2022.12.031. Epub 2023 Jan 14.
  PMID: 36646388
  responsible party type: Sponsor
  mesh term: Mucositis
  mesh term: Stomatitis
  mesh term: Cisplatin
  sharing ipd: No