ROMAN: A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
Sponsor
Galera Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03689712
Collaborator
(none)
455
97
2
61.9
4.7
0.1
Study Details
Study Description
Brief Summary
The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
455 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer
Actual Study Start Date
:
Oct 3, 2018
Actual Primary Completion Date
:
Aug 13, 2021
Anticipated Study Completion Date
:
Dec 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GC4419
|
Drug: GC4419
60 minute IV infusion
|
| Placebo Comparator: Placebo
|
Drug: Placebo
60 minute IV infusion
|
Outcome Measures
Primary Outcome Measures
- Cumulative incidence of severe OM [From the first IMRT fraction through the end of the study treatment period, which is estimated to be 7 weeks.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
squamous cell carcinoma of the head and neck
-
treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
-
Treatment plan to receive standard cisplatin monotherapy
-
Age 18 years or older
-
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
-
Adequate hematologic, renal and liver function
-
Negative serum pregnancy test
-
Use of effective contraception
Exclusion Criteria:
-
Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
-
Metastatic disease
-
Prior radiotherapy to the region of the study cancer or adjacent anatomical
-
Prior induction chemotherapy
-
Receiving any approved or investigational anti-cancer agent other than those provided for in this study
-
Concurrent participation in another interventional clinical study
-
Inability to eat soft solid food at baseline
-
Malignant tumors other than HNC within the last 5 years
-
Active infectious disease excluding oral candidiasis
-
Presence of oral mucositis at baseline
-
Known history of HIV or active hepatitis B/C
-
Female patients who are pregnant or breastfeeding
-
Known allergies or intolerance to cisplatin and similar platinum-containing compounds
-
Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 2 | Fowler Family Center for Cancer | Jonesboro | Arkansas | United States | 72401 |
| 3 | The Oncology Institute of Hope & Innovation | Corona | California | United States | 92882 |
| 4 | Chan Soon-Shiong Institute for Medicine | Costa Mesa | California | United States | 92627 |
| 5 | Long Beach Veteran Affairs Healthcare System | Long Beach | California | United States | 90822 |
| 6 | USC Norris Cancer Center | Los Angeles | California | United States | 90033 |
| 7 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 8 | Clinical Trials and Research Associates, Inc. | Montebello | California | United States | 90640 |
| 9 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92663 |
| 10 | Compassionate Cancer Care | Riverside | California | United States | 92501 |
| 11 | Sharp Clinical Oncology Research | San Diego | California | United States | 92123 |
| 12 | The Oncology Institute of Hope & Innovation | Whittier | California | United States | 90603 |
| 13 | Dignity Health Research Institute | Woodland | California | United States | 95695 |
| 14 | St. Mary's Hospital Regional Medical Center | Grand Junction | Colorado | United States | 81501 |
| 15 | Bay Pines VA HealthCare System | Bay Pines | Florida | United States | 33744 |
| 16 | Boca Raton Regional Hospital, Lynn Cancer Institute | Boca Raton | Florida | United States | 33486 |
| 17 | Mayo Clinic Florida | Jacksonville | Florida | United States | 32224 |
| 18 | Cancer Specialists of North Florida | Jacksonville | Florida | United States | 32256 |
| 19 | Lakeland Regional Cancer Center | Lakeland | Florida | United States | 33805 |
| 20 | BRCR Global | Plantation | Florida | United States | 33322 |
| 21 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 22 | IACT Health | Columbus | Georgia | United States | 31904 |
| 23 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 24 | SwedishAmerican Regional Cancer Center | Rockford | Illinois | United States | 61114 |
| 25 | Parkview Research Center | Fort Wayne | Indiana | United States | 46845 |
| 26 | Goshen Center for Cancer Care | Goshen | Indiana | United States | 46526 |
| 27 | The University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
| 28 | Appalachian Regional Healthcare, INC. | Hazard | Kentucky | United States | 41701 |
| 29 | University of Louisville/James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 30 | Norton Cancer Institute | Louisville | Kentucky | United States | 40241 |
| 31 | MetroWest Medical Center | Framingham | Massachusetts | United States | 01702 |
| 32 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 33 | Minneapolis VA Healthcare System | Minneapolis | Minnesota | United States | 55417 |
| 34 | Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | United States | 39401 |
| 35 | Henry Ford Allegiance Health Hematology Oncology | Jackson | Mississippi | United States | 49201 |
| 36 | Ellis Fischel Cancer Center - University of Missouri | Columbia | Missouri | United States | 65212 |
| 37 | Delbert Day Cancer Institute, Phelps County Regional Medical Center | Rolla | Missouri | United States | 65401 |
| 38 | Mosaic Life Care/Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64507 |
| 39 | Cox Medical Center | Springfield | Missouri | United States | 65807 |
| 40 | St. Vincent Frontier Cancer Center | Billings | Montana | United States | 59102 |
| 41 | Benefis Sletten Cancer institute | Great Falls | Montana | United States | 59405 |
| 42 | CHI Health St. Francis | Grand Island | Nebraska | United States | 68803 |
| 43 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 44 | Exeter Hospital | Exeter | New Hampshire | United States | 03833 |
| 45 | Hunterdon Hematology Oncology, LLC | Flemington | New Jersey | United States | 08822 |
| 46 | Summit Medical Group | Florham Park | New Jersey | United States | 07932 |
| 47 | Jersey Shore University Medical Center | Neptune | New Jersey | United States | 07753 |
| 48 | New York Oncology Hematology, P.C. | Albany | New York | United States | 12206 |
| 49 | NY Cancer and Blood Specialists | East Setauket | New York | United States | 11733 |
| 50 | New York- Presbyterian Queens/ Weill Cornell | Flushing | New York | United States | 11355 |
| 51 | Wilmot Cancer Institute - Univeristy of Rochester | Rochester | New York | United States | 14642 |
| 52 | School of Dental Medicine at East Carolina University | Greenville | North Carolina | United States | 27834 |
| 53 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
| 54 | Summa Health | Akron | Ohio | United States | 44304 |
| 55 | University Hospitals Seidman Cancer Center | Cleveland | Ohio | United States | 44106 |
| 56 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 57 | Willamette Valley Cancer Institue and Research Center | Eugene | Oregon | United States | 97401 |
| 58 | VA Portland Health Care System | Portland | Oregon | United States | 97239 |
| 59 | St. Luke's Hospital Cancer Center | Easton | Pennsylvania | United States | 18045 |
| 60 | Gettysburg Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 61 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 62 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 63 | Anmed Health Cancer Center | Anderson | South Carolina | United States | 29621 |
| 64 | Charleston Cancer Center | Charleston | South Carolina | United States | 29406 |
| 65 | St. Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 66 | Spartanburg Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 67 | Mountain States Health Alliance Research Dept | Johnson City | Tennessee | United States | 37604 |
| 68 | Tennessee Cancer Specialists | Knoxville | Tennessee | United States | 37909 |
| 69 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 70 | Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center | Beaumont | Texas | United States | 77702 |
| 71 | Texas Oncology- Dallas Presbyterian Hospital | Dallas | Texas | United States | 75231 |
| 72 | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 73 | Texas Oncology - Denton South | Denton | Texas | United States | 76210 |
| 74 | Texas Oncology - El Paso Cancer Treatment Center | El Paso | Texas | United States | 79902 |
| 75 | SAMMC | Fort Sam Houston | Texas | United States | 78234 |
| 76 | Texas Oncology-McAllen | McAllen | Texas | United States | 78503 |
| 77 | Texas Oncology - McKinney | McKinney | Texas | United States | 75071 |
| 78 | Texas Oncology, Plano West | Plano | Texas | United States | 75093 |
| 79 | Baylor Scott & White- Round Rock | Round Rock | Texas | United States | 78665 |
| 80 | Texas Oncology - Sugar Land | Sugar Land | Texas | United States | 77479 |
| 81 | Texas Oncology - Waco | Waco | Texas | United States | 76712 |
| 82 | Fort Belvoir Community Hospital | Fort Belvoir | Virginia | United States | 22060 |
| 83 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia | United States | 24014 |
| 84 | Providence Regional Cancer Partnership | Everett | Washington | United States | 98201 |
| 85 | Cancer Care Northwest | Spokane | Washington | United States | 99216 |
| 86 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
| 87 | BC Cancer Center - Vancouver | Vancouver | British Columbia | Canada | V574E6 |
| 88 | CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont | Montréal | Quebec | Canada | H1T 2M4 |
| 89 | McGill University Health Center- Cedars Cancer Center | Montréal | Quebec | Canada | H4A 3J1 |
| 90 | CHU de Quebec - Universite Laval | Québec | Quebec | Canada | G1R 2J6 |
| 91 | Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean | Chicoutimi | Canada | G7H 5H6 | |
| 92 | Juravinski Cancer Centre | Hamilton | Canada | L8V 5C2 | |
| 93 | Centre Hospitalier Universitaire de Montreal (CHUM) | Montréal | Canada | H2X OC1 | |
| 94 | Jewish General Hospital | Montréal | Canada | H3T 1E2 | |
| 95 | Northeast Cancer Centre of Health Sciences North | Sudbury | Canada | P3E 5J1 | |
| 96 | Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec | Trois-Rivières | Canada | G8Z3R9 | |
| 97 | Clinical Research Puerto Rico | San Juan | Puerto Rico | 00909 |
Sponsors and Collaborators
- Galera Therapeutics, Inc.
Investigators
- Study Chair: Jon T. Holmlund, MD, Chief Medical Officer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03689712
Other Study ID Numbers:
- GTI-4419-301
First Posted:
Sep 28, 2018
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Galera Therapeutics, Inc.
Additional relevant MeSH terms: