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The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and 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.
GT-201 is a randomized, double-blind, placebo-controlled, multi-center study conducted in the U.S. to evaluate GC4419 administered via an intravenous line (IV) for the reduction of incidence, duration, and severity of radiation induced oral mucositis in patients receiving cisplatin plus intensity-modulated radiation therapy for post-operative, or definitive treatment of locally advanced, non-metastatic squamous cell carcinoma of the head and neck, limited to the oral cavity or oropharynx. Patients will be randomized equally to 1 of 3 treatment arms:
Arm A: 30 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm B: 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm C: Placebo daily (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy.
All patients will be assessed twice weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 8 weeks, or until oral mucositis resolves to ≤ Grade 1.
Approximately 200 total to ensure that roughly 60 patients per arm receive study drug and complete requirements for primary endpoint analysis, which is defined as patients receiving a minimum cumulative dose of 60 Gy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose GC4419: 30mg/day | Experimental | 30 mg GC4419/day prior to IMRT |
|
| High Dose GC4419: 90mg/day | Experimental | 90 mg GC4419/day prior to IMRT |
|
| Placebo | Placebo Comparator | Placebo daily, prior to IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose GC4419: 30mg/day | Drug | Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration (in Days) of Radiation Induced Severe Oral Mucositis (OM) Per World Health Organization (WHO) Criteria | Assessed from the first determination of ≥Grade 3 OM to the first instance of non-severe OM (≤Grade 2), without a subsequent instance of ≥Grade 3 | From start of Intensity-modulated radiation therapy (IMRT) through 8 weeks follow-up, an average of 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Number of participants with treatment emergent adverse events (TEAE) per arm | First dose of IMRT through the completion of IMRT, estimated to be up to 7 weeks. |
| Number of Participants Who Experience Severe OM |
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Inclusion Criteria:
Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck, defined as SCC of the oral cavity or oropharynx that will be treated with cisplatin plus concurrent IMRT Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criteria #2 and #3 below are eligible for the trial.
Treatment plan to receive a continuous course of IMRT delivered as 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 > 50 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.
Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (80-100 mg/m2 for 3 doses) or weekly (30-40 mg/m2 for 6-7 doses). The decision on which chemotherapy regimen to use in combination with IMRT and GC4419 will be at the discretion of the investigator.
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate hematologic function as indicated by:
Adequate renal and liver function as indicated by:
Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test
Serum pregnancy test negative for females of childbearing potential
Males and females must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the last dose of GC4419
Properly obtained written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon T Holmlund, MD | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center at Dignity Health St. Joseph's | Phoenix | Arizona | 85004 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36640725 | Derived | Mapuskar KA, Vasquez Martinez G, Pulliam CF, Petronek MS, Steinbach EJ, Monga V, Furqan M, Jetton JG, Saunders DP, Pearce A, Davidson S, Pitre L, Dunlap NE, Fairbanks R, Lee CM, Mott SL, Bodeker KL, Cl H, Buatti JM, Anderson CM, Beardsley RA, Holmlund JT, Zepeda-Orozco D, Spitz DR, Allen BG. Avasopasem manganese (GC4419) protects against cisplatin-induced chronic kidney disease: An exploratory analysis of renal metrics from a randomized phase 2b clinical trial in head and neck cancer patients. Redox Biol. 2023 Apr;60:102599. doi: 10.1016/j.redox.2022.102599. Epub 2023 Jan 3. | |
| 35724774 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose GC4419: 30mg/Day | 30 mg GC4419/day prior to IMRT Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
| 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 | Yes | No | No | Study Protocol | Oct 19, 2017 | Apr 2, 2021 |
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| High Dose GC4419: 90mg/day | Drug | High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). |
|
| Placebo | Drug | Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). |
|
| Intensity-Modulated Radiation Therapy | Radiation | Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks |
|
| Cisplatin | Drug | Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
Number of participants who experience severe OM from the first IMRT fraction through the last IMRT fraction |
| Minimum of 60 Gy administered to tumor, approximately 30 IMRT fractions, which is estimated to be 6-7 weeks. |
| Number of Participants Who Experienced Grade 4 OM From the First IMRT Fraction Through the Last IMRT Fraction | Number of Participants who experienced Grade 4 OM | First dose of IMRT through the completion of IMRT, estimated to be up to 6-7 weeks. |
| Number of IMRT Fractions Delivered at Onset of Severe OM | Onset of severe OM: number of IMRT fractions delivered at onset of severe OM | Onset of Severe OM, estimated to be between first dose of IMRT and 7 weeks. |
| Number of Participants Who Experienced Grade 4 Oral Mucocitis (OM) From the First IMRT Fraction Through the Last IMRT Fraction | Number of Participants who experienced Grade 4 OM | Onset of Grade 4 OM, estimated to be between first dose of IMRT and 7 weeks. |
| Number of Participants With Tumor Outcomes Defined as Locoregional Failure, Distant Metastases, Disease Progression and Deaths | Effect of treatment assignment on tumor outcomes (locoregional failure, distant metastases, progression-free survival, overall survival) Only 73 subjects in Placebo Arm were analyzed for locoregional failure, distant disease and progression-free survival because 1 subject was determined after enrollment to have a non-head and neck cancer and was therefore excluded from these analyses | Up to 1 year following completion of chemoradiation. |
| University of Arizona |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Fowler Family Center for Cancer Care | Jonesboro | Arkansas | 72401 | United States |
| University of Arkansas for Medical Sciences- Winthrop P. Rockefeller Cancer Institute | Little Rock | Arkansas | 72205 | United States |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Clinical Trials and Research Associates, Inc. | Montebello | California | 90604 | United States |
| UC Irvine Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Stanford Cancer Institute | Stanford | California | 94305 | United States |
| St. Mary's Regional Cancer Center | Grand Junction | Colorado | 81501 | United States |
| UConn Health School of Dental Medicine | Farmington | Connecticut | 06030 | United States |
| Pasco Pinellas Cancer Center | Holiday | Florida | 34691 | United States |
| Lakeland Regional Health Cancer Center | Lakeland | Florida | 32504 | United States |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| Sacred Heart Medical Oncology Group | Pensacola | Florida | 32504 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Indianan, Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Department of Radiation Oncology University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Ashland-Bellefonte Cancer Center | Ashland | Kentucky | 41101 | United States |
| University of Kentucky, Albert B. Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| University of Louisville Hospital, James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| CHRISTUS Schumpert Cancer Treatment Center | Shreveport | Louisiana | 71101 | United States |
| Baystate Regional Cancer Program | Springfield | Massachusetts | 01199 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Allegiance Health | Jackson | Michigan | 49201 | United States |
| Lake Huron Medical Center | Port Huron | Michigan | 48060 | United States |
| Ellis Fichel Cancer Center, University of Missouri | Columbia | Missouri | 65212 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Renown Cancer Institute | Reno | Nevada | 89502 | United States |
| Hunterdon Hematology Oncology, LLC Hunterdon Regional Cancer Center | Flemington | New Jersey | 08822 | United States |
| Jersey Shore University Medical Center- Hackensack Meridian Health | Neptune City | New Jersey | 07753 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| East Carolina University, Leo W. Jenkins Cancer Center | Greenville | North Carolina | 27834 | United States |
| Marion L. Shepard Cancer Center | Washington | North Carolina | 27889 | United States |
| Wake Forest Health | Winston-Salem | North Carolina | 27157 | United States |
| Ohio State University, James Cancer Center | Columbus | Ohio | 43210 | United States |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| VA Portland Health Care System | Portland | Oregon | 97239 | United States |
| St. Luke's University Health Network | Easton | Pennsylvania | 18045 | United States |
| Thomas-Jefferson University Hospital-Bodine Center for Cancer Treatment | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital, Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Prairie Lakes Health Care System | Watertown | South Dakota | 57201 | United States |
| Mountain States Health Alliance | Johnson City | Tennessee | 36704 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Texas Oncology | Plano | Texas | 75093 | United States |
| Scott and White Memorial Hospital and Clinic | Temple | Texas | 76508 | United States |
| Hope Cancer Center | Tyler | Texas | 75701 | United States |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Providence Regional Medical Center | Everett | Washington | 98201 | United States |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| Cancer Care Northwest | Spokane | Washington | 99216 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Northeast Cancer Centre, Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Jewish General Hospital | Montreal | Quebec | Canada |
| Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-centre-du-Québec | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Fundación de Investigación | San Juan | PR | 00927 | Puerto Rico |
| Derived |
| Anderson CM, Lee CM, Saunders D, Curtis AE, Dunlap NE, Nangia C, Lee AS, Kovoor P, Bar-Ad V, Pedadda AV Jr, Holmlund J, Downs M, Sonis ST. Two-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer. Int J Radiat Oncol Biol Phys. 2022 Nov 1;114(3):416-421. doi: 10.1016/j.ijrobp.2022.06.063. Epub 2022 Jun 17. |
| FG001 | High Dose GC4419: 90mg/Day | 90 mg GC4419/day prior to IMRT High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
| FG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose GC4419: 30mg/Day | 30 mg GC4419/day prior to IMRT Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
| BG001 | High Dose GC4419: 90mg/Day | 90 mg GC4419/day prior to IMRT High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
| BG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
| BG003 | 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 (NIH/OMB) | Count of Participants | 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 (in Days) of Radiation Induced Severe Oral Mucositis (OM) Per World Health Organization (WHO) Criteria | Assessed from the first determination of ≥Grade 3 OM to the first instance of non-severe OM (≤Grade 2), without a subsequent instance of ≥Grade 3 | intent to treat population | Posted | Median | Full Range | days | From start of Intensity-modulated radiation therapy (IMRT) through 8 weeks follow-up, an average of 15 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | Number of participants with treatment emergent adverse events (TEAE) per arm | Treated Population | Posted | Number | participants | First dose of IMRT through the completion of IMRT, estimated to be up to 7 weeks. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Severe OM | Number of participants who experience severe OM from the first IMRT fraction through the last IMRT fraction | Intent to treat population | Posted | Number | participants | Minimum of 60 Gy administered to tumor, approximately 30 IMRT fractions, which is estimated to be 6-7 weeks. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Grade 4 OM From the First IMRT Fraction Through the Last IMRT Fraction | Number of Participants who experienced Grade 4 OM | Intent to treat population | Posted | Number | participants | First dose of IMRT through the completion of IMRT, estimated to be up to 6-7 weeks. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of IMRT Fractions Delivered at Onset of Severe OM | Onset of severe OM: number of IMRT fractions delivered at onset of severe OM | Intent to treat population | Posted | Median | 95% Confidence Interval | IMRT Fractions | Onset of Severe OM, estimated to be between first dose of IMRT and 7 weeks. |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Grade 4 Oral Mucocitis (OM) From the First IMRT Fraction Through the Last IMRT Fraction | Number of Participants who experienced Grade 4 OM | Intent to Treat Population | Posted | Number | participants | Onset of Grade 4 OM, estimated to be between first dose of IMRT and 7 weeks. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tumor Outcomes Defined as Locoregional Failure, Distant Metastases, Disease Progression and Deaths | Effect of treatment assignment on tumor outcomes (locoregional failure, distant metastases, progression-free survival, overall survival) Only 73 subjects in Placebo Arm were analyzed for locoregional failure, distant disease and progression-free survival because 1 subject was determined after enrollment to have a non-head and neck cancer and was therefore excluded from these analyses | Intent to treat population | Posted | Count of Participants | Participants | Up to 1 year following completion of chemoradiation. |
|
from first dose study drug through 30 days after last dose, approximately 11 weeks
All-cause mortality was reported for all randomized intent-to-treat subjects (ITT) (inclusive of randomization failures who did not get treated). Adverse Events (AEs)/Serious Adverse Events (SAEs) were analyzed for only subjects who received at least one dose of study drug (treated population)
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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 | Low Dose GC4419: 30mg/Day | 30 mg GC4419/day prior to IMRT Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor | 1 | 73 | 34 | 73 | 73 | 73 |
| EG001 | High Dose GC4419: 90mg/Day | 90 mg GC4419/day prior to IMRT High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor | 1 | 76 | 34 | 72 | 72 | 72 |
| EG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor | 2 | 73 | 28 | 72 | 72 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malnutrition | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Failure to thrive | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Stoma site pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Terry | Galera Therapeutics, Inc. | 610-725-1500 | kterry@galeratx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2017 | Jun 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707700 | avasopasem manganese |
| D050397 | Radiotherapy, Intensity-Modulated |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
|
| OG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
|
| OG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
|
| OG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
|
| OG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
|
| OG002 | Placebo | Placebo daily, prior to IMRT Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks). Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses. Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor |
|
|