Condition or disease | Intervention/treatment | Phase |
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Oral Mucositis | Drug: RRx-001 Drug: Cisplatin for injection Radiation: Radiation Therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
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 |
Actual Study Start Date : | July 12, 2018 |
Actual Primary Completion Date : | October 22, 2019 |
Actual Study Completion Date : | October 8, 2020 |
Arm | Intervention/treatment |
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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
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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
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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
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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
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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
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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).
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
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:
Exclusion Criteria:
United States, California | |
John Wayne Cancer Institute @ Providence St. John's Health Center | |
Santa Monica, California, United States, 90401 | |
United States, Colorado | |
Centura Health Research Center | |
Denver, Colorado, United States, 80210 | |
United States, District of Columbia | |
George Washington University | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Florida Hospital | |
Orlando, Florida, United States, 32804 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
United States, North Carolina | |
East Carolina University | |
Greenville, North Carolina, United States, 27834 | |
United States, Ohio | |
University of Cincinnati Medical Center | |
Cincinnati, Ohio, United States, 45267 | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Ballad Health | |
Johnson City, Tennessee, United States, 37604 | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
UT Southwestern | |
Dallas, Texas, United States, 75390 |
Study Director: | Bryan Oronsky, MD, PhD | EpicentRx, Inc. |
Tracking Information | |||||
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First Submitted Date ICMJE | April 18, 2018 | ||||
First Posted Date ICMJE | May 3, 2018 | ||||
Last Update Posted Date | January 11, 2021 | ||||
Actual Study Start Date ICMJE | July 12, 2018 | ||||
Actual Primary Completion Date | October 22, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 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 5=oral alimentation impossible. Sever 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 Sever Oral Mucositis duration numbers are indicative of worst outcomes. The total Sever 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.
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Original Primary Outcome Measures ICMJE |
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).
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers | ||||
Official Title ICMJE | 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 | ||||
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 is only one approved therapy to treat or prevent it. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Oral Mucositis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
48 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Actual Study Completion Date ICMJE | October 8, 2020 | ||||
Actual Primary Completion Date | October 22, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03515538 | ||||
Other Study ID Numbers ICMJE | PR-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | EpicentRx, Inc. | ||||
Study Sponsor ICMJE | EpicentRx, Inc. | ||||
Collaborators ICMJE | Prothex Pharma, Inc. | ||||
Investigators ICMJE |
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PRS Account | EpicentRx, Inc. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |