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| Name | Class |
|---|---|
| Prothex, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRx-001 Pre-Treatment plus SOC | Experimental | 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 |
|
| RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC | Experimental | 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 |
|
| RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC | Experimental | 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 |
|
| Standard of Care | Active Comparator | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RRx-001 | Drug | RRx-001 for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe Oral Mucositis (SOM) | Duration in days of severe oral mucositis (SOM). Defined as oral mucositis grade 3 or 4 on the WHO Mucositis Grading Scale which comprises 5 grades: 0 = none, 1= oral soreness, erythema, 2 = oral erythema, ulcers, solid diet tolerated, 3 = oral ulcers, liquid diet only, and 4 = oral alimentation impossible. Severe Oral Mucositis duration is obtained by totaling the number of days a given patient experiences oral mucositis grade 3 or 4 during the randomized treatment period. Higher Severe Oral Mucositis duration numbers are indicative of worst outcomes. The total Severe Oral Mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period. | From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Severe Oral Mucositis | Time to onset of Severe Oral Mucositis defined as time (in days) from randomization to the first observed Severe Oral Mucositis. Longer Severe Oral Mucositis onset times are indicative of a better outcome. The time to onset of Severe Oral Mucositis for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period. |
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Inclusion Criteria:
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
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.
ECOG performance status ≤ 2.
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
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
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.
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 to understand and sign a written informed consent document.
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Oronsky, MD, PhD | EpicentRx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Institute @ Providence St. John's Health Center | Santa Monica | California | 90401 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 RRx-001: RRx-001 for injection 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 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2018 |
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|
| Cisplatin for injection | Drug | 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 Therapy | Radiation | 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 |
|
| Time from Day 1 to Oral Mucositis Onset (up to 8 weeks) |
| Incidence of Severe Oral Mucositis | Incidence of Severe Oral Mucositis defined as the number of patients who experienced a Severe Oral Mucositis grade 4 during the randomized treatment period. | Baseline through end of treatment (up to 11 weeks). Data collected every week. |
| Opioid Use | Opioid use from the time to onset (TTO) and duration of opioid use among patients who were not taking opioids at radiation start or who required a second opioid during active treatment. | Baseline through end of radiation treatment (through 8 weeks). Data collected every week. |
| Centura Health Research Center |
| Denver |
| Colorado |
| 80210 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Ballad Health | Johnson City | Tennessee | 37604 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| FG001 | 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 RRx-001: RRx-001 for injection 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 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 |
| FG002 | 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 RRx-001: RRx-001 for injection 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 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 |
| FG003 | 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). 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 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 |
| COMPLETED |
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| NOT COMPLETED |
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|
Safety Population comprises all subjects who are randomized and received at least 1 dose of study drug and will be used for all analyses of safety. Analysis is based on actual treatment group
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 RRx-001: RRx-001 for injection 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 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 |
| BG001 | 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 RRx-001: RRx-001 for injection 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 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 |
| BG002 | 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 RRx-001: RRx-001 for injection 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 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 |
| BG003 | 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). 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 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Severe Oral Mucositis (SOM) | Duration in days of severe oral mucositis (SOM). Defined as oral mucositis grade 3 or 4 on the WHO Mucositis Grading Scale which comprises 5 grades: 0 = none, 1= oral soreness, erythema, 2 = oral erythema, ulcers, solid diet tolerated, 3 = oral ulcers, liquid diet only, and 4 = oral alimentation impossible. Severe Oral Mucositis duration is obtained by totaling the number of days a given patient experiences oral mucositis grade 3 or 4 during the randomized treatment period. Higher Severe Oral Mucositis duration numbers are indicative of worst outcomes. The total Severe Oral Mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period. | All participants: number of days from the start of oral mucositis greater than a grade zero until resolution. | Posted | Mean | Standard Deviation | Days | From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Severe Oral Mucositis | Time to onset of Severe Oral Mucositis defined as time (in days) from randomization to the first observed Severe Oral Mucositis. Longer Severe Oral Mucositis onset times are indicative of a better outcome. The time to onset of Severe Oral Mucositis for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period. | All participants: number of days from start of treatment until participant experiences a OM grade of greater than zero. | Posted | Median | 95% Confidence Interval | Days to Onset | Time from Day 1 to Oral Mucositis Onset (up to 8 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Severe Oral Mucositis | Incidence of Severe Oral Mucositis defined as the number of patients who experienced a Severe Oral Mucositis grade 4 during the randomized treatment period. | All participants who received study treatment and who experienced Oral Mucositis score greater than zero. | Posted | Count of Participants | Participants | Baseline through end of treatment (up to 11 weeks). Data collected every week. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Opioid Use | Opioid use from the time to onset (TTO) and duration of opioid use among patients who were not taking opioids at radiation start or who required a second opioid during active treatment. | Participants who required opioid use during treatment. | Posted | Count of Participants | Participants | Baseline through end of radiation treatment (through 8 weeks). Data collected every week. |
|
Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks.
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 RRx-001: RRx-001 for injection 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 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 | 0 | 12 | 4 | 12 | 9 | 12 |
| EG001 | 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 RRx-001: RRx-001 for injection 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 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 | 0 | 11 | 4 | 11 | 10 | 11 |
| EG002 | 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 RRx-001: RRx-001 for injection 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 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 | 1 | 13 | 6 | 13 | 12 | 13 |
| EG003 | 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). 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 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 | 0 | 10 | 5 | 10 | 6 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Salivary duct inflammation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Flank pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Swelling face | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Oronsky | EpicentRx, Inc | 858-229-1062 | mstirn@epicentrx.com |
| Jul 29, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2018 | Jul 29, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577469 | RRx-001 |
| D002945 | Cisplatin |
| D007267 | Injections |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
|
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 RRx-001: RRx-001 for injection 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 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 |
| OG002 | 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 RRx-001: RRx-001 for injection 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 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 |
| OG003 | 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). 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 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 |
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|
| OG002 | 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 RRx-001: RRx-001 for injection 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 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 |
| OG003 | 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). 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 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 |
|
|
| OG002 | 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 RRx-001: RRx-001 for injection 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 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 |
| OG003 | 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). 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 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 |
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