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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00264 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PA091105_A04PAMDREVW01 | |||
| A091105 | |||
| A091105 | Other Identifier | Alliance for Clinical Trials in Oncology | |
| A091105 | Other Identifier | CTEP | |
| R01FD005105 | U.S. FDA Grant/Contract | View source | |
| U10CA180821 | U.S. NIH Grant/Contract | View source | |
| U10CA031946 | U.S. NIH Grant/Contract | View source |
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This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. [Funding Source - FDA OOPD]
PRIMARY OBJECTIVES:
I. To compare the progression-free survival (PFS) rates of patients with desmoid tumors (DT)/deep fibromatosis (DF) who receive either sorafenib (sorafenib tosylate) or placebo using a double-blinded randomized phase III study.
SECONDARY OBJECTIVES:
I. To assess toxicity. II. To assess time to surgical intervention. III. To assess tumor response rates and survival.
TERTIARY OBJECTIVES:
I. To evaluate changes in magnetic resonance imaging (MRI) Tesla (T)2 to predict (or correlate) with a biological effect such as tumor growth (by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1), and pain palliation. (Correlative companion study) II. The mechanism of action of sorafenib in DT/DF remains unknown. In patients consenting to undergo the paired tumor biopsies (A091105-ST1), treatment induced changes will be quantified by histology, gene expression profiling, proteomic changes and selected interrogation of key pathways by western blot and reverse transcription-polymerase chain reaction (RT-PCR). (Correlative companion study) III. To collect archival tissue, baseline (tumor, blood) and day 8 (tumor, blood) specimens for basic science research (A091105-ST1). (Correlative companion study) IV. To assess patient-reported adverse events and quality of life (QOL) as measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the single-item overall Linear Analogue Self-Assessment (LASA) (A091105-HO1). (Correlative companion study) V. To assess pain palliation measured by the "worst pain" item of the Brief Pain Inventory Short Form (A091105-HO1). (Correlative companion study)
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sorafenib tosylate orally (PO) once daily (QD) on days 1-28.
ARM II: Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (sorafenib tosylate) | Experimental | Patients receive sorafenib tosylate PO QD on days 1-28. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Optional correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival(PFS) Rate | PFS is defined as the time from randomization to the first occurrence of progression or death due to any cause. If no event exists, the PFS will be censored at the last disease assessment. Data following cross over will be analyzed and summarized separately from the data from the main course of treatment for these patients in an exploratory and hypothesis generating manner. Intention to treat principles will be used. Patient disease status was evaluated using RECSIT v1.1. Patients ending treatment for symptomatic deterioration without radiographic evidence of PD, were classified as having PD. Otherwise, patients not yet showing disease progression were classified as having no progression at the most recent disease assessment and in the following cases: crossing over to receive sorafenib, date of first non-protocol directed anti-cancer therapy, lost to follow-up, withdrawal of consent, and changing imaging methods from that which was used at study entry. | Time from randomization to the first occurrence of progression or death due to any cause, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Using the Patient Reported Outcomes-Common Terminology Criteria in Adverse Events Version 4.0 | INCLUDED IN THE ADVERSE EVENTS PORTION OF THE RESULTS SECTION. Frequency tables, summary statistics, and categorical analysis will be used to compare the distributions of toxicity for patients treated with sorafenib tosylate vs placebo. Data for patients who have crossed over or having received surgical or radiotherapy intervention will be summarized independently from their primary course of study treatment in an exploratory and hypothesis generating manner. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Tumor Size by Response Evaluation Criteria in Solid Tumors Version 1.1 (Correlative Companion Study-Imaging Study) | Best response (ordinal variable) and percent T2 signal change (continuous) will be correlated by Spearman?s rho. | Baseline up to 3 years |
| Percent Changes in MRI T2 Signal (Correlative Companion Study-Imaging Study) |
Inclusion Criteria:
Patients must have confirmation of DT/DF by local pathologist prior to registration
Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2
Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration (6 weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade 2
Patients with prior or current treatment of sorafenib are excluded
No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with sorafenib:
Boceprevir
Indinavir
Nelfinavir
Lopinavir/ritonavir
Saquinavir
Telaprevir
Ritonavir
Clarithromycin
Conivaptan
Itraconazole
Ketoconazole
Mibefradil
Nefazodone
Posaconazole
Voriconazole
Telithromycin
Chronic daily NSAID use as treatment for controlling desmoid tumors is not allowed, and should be stopped >= 3 days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis)
Patients must have measurable disease
Patients have to meet one of the following criteria to be eligible:
Disease determined unresectable or entailing unacceptably morbid surgery based on 1 or more of the following characteristics:
Progression by radiographic imaging (10% increase in size by RECIST v1.1 within 6 months of registration)
Patients with symptomatic disease which meets the following criteria Brief Pain Inventory (BPI) score greater than or equal to 3 AND one of the following:
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients who are pregnant or nursing are not eligible
No patients with a history of cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); active coronary artery disease (CAD) (myocardial infarction or unstable angina within 6 months prior to study entry)
No patients with inadequately controlled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy
No patients with clinically significant gastrointestinal (GI) bleeding or bleeding diathesis within 30 days prior to registration
Absolute neutrophil count >= 1,500/mm^3
Hemoglobin >= 8 g/dl
Platelets >= 75,000/mm^3
Total bilirubin =< 1.5 x upper limits of normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])/serum glutamate pyruvate transaminase (SGPT) (aspartate aminotransferase [ALT]) =< 1.5 x ULN
Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation
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| Name | Affiliation | Role |
|---|---|---|
| Mrinal M Gounder | Alliance for Clinical Trials in Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34420143 | Derived | Mazza GL, Petersen MM, Ginos B, Langlais BT, Heon N, Gounder MM, Mahoney MR, Zoroufy AJ, Schwartz GK, Rogak LJ, Thanarajasingam G, Basch E, Dueck AC. Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2. Qual Life Res. 2022 Apr;31(4):1069-1080. doi: 10.1007/s11136-021-02968-1. Epub 2021 Aug 21. | |
| 33258687 | Derived | Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104-114. doi: 10.1177/1740774520975120. Epub 2020 Dec 1. |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Sorafenib Tosylate) | Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day |
| FG001 | Arm II (Placebo) | Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression. |
| 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 | Dec 18, 2018 |
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| Placebo Administration | Other | Given PO |
|
| Quality-of-Life Assessment | Other | Optional ancillary studies |
|
|
| Sorafenib Tosylate | Drug | Given PO |
|
|
| Up to 3 years |
| Time to Surgical Intervention During Treatment | A log rank test will be used to compare the distributions of time to surgical intervention between the two arms using a 2-sided test and alpha=0.05 level of significance. Kaplan-Meier methodology will be used to estimate various time points and 95% confidence intervals will be calculated for these estimates. Surgery will be classified by outcome (eg, complete-macroscopic, complete-microscopic, or partial), type, location (eg, limb), thereafter analyzed by categorical analysis and descriptive statistics. Non-parametric methods will be used, as appropriate. Too few patients had surgery during treatment to perform analysis. | Time between randomization to the patient undergoing therapeutic surgical resection for this disease, assessed up to 3 years |
| Overall Survival | Kaplan-Meier methodology and log rank tests will be used to compare overall survival between the groups at various time points (eg, 1 year rate, 2 year rate, etc) and 95% confidence intervals will be calculated for these estimates. Data following crossover will be analyzed and summarized separately from the main course of treatment for these patients in an exploratory and hypothesis generating manner. | Time between the date of randomization to until death, assessed up to 3 years |
| Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1 | Compared between the two treatment arms and using the Cochran-Mantel-Haenszel test. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. Patients on Arm II (placebo) who crossover are censored for Best Objective Status at the time of crossover. | Up to 3 years |
| Duration of Response | Kaplan Meier methodology will be used to estimate the distribution of duration of response and the log-rank test will be used to test for a difference in duration of response between the two arms. Patients on Arm II (placebo) who crossover are censored for Duration of Response at the time of crossover. | Time between first tumor response and progression, assessed up to 3 years |
Percent T2 signal change (continuous) will be correlated by Spearman?s rho. The percent changes in MRI T2 signal from Week 8 to subsequent imaging will be compared between groups with > 30% pain palliation using t-test or a nonparametric alternative (e.g., Wilcoxon rank-sum test). |
| Baseline up to 3 years |
| Time to Pain Progression Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study- A091105-H01 QOL Study) | Defined as a >= 30% increase compared with baseline in the worst pain intensity score (BPI-SF ?worst pain? item) or either a >= 30% increase in the average daily use of any type of opioid narcotic or the addition of a new opioid narcotic compared with baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. | Date of randomization to the earliest date that pain progression is observed, assessed up to 12 weeks |
| Time to Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study-A091105-H01 QOL Study) | Defined at each time point as >= 30% decrease from baseline in the worst pain intensity score (BPI-SF ?worst pain? item), with neither a concomitant >= 30% increase in average daily use of any opioid narcotic, nor addition of any new opioid narcotic, relative to baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. | Date of randomization to the earliest date that confirmed pain palliation is observed, assessed up to 12 weeks |
| Duration of Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study- A091105-H01 QOL Study) | Defined for all patients who experience confirmed pain palliation. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group. | Time from the earliest date that confirmed pain palliation is observed to the earliest date that pain progression is observed, assessed up to 12 weeks |
| Rate of Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study-A091105-H01 QOL Study) | Rate of pain palliation at week 8 confirmed as week 12 will be compared between arms using a two-sided alpha=0.05 chi-squared tests at the time of the final analysis. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group. | Baseline up to 12 weeks |
| Cadherin-associated Protein, Beta 1 (CTNNB1) Genotype (Correlative Companion Study-A091105-ST1 Study) | Associations among the possible predictors of response to sorafenib and CTNNBI mutations will be examined using Fisher?s exact test, Kruskal-Wallis test, or Spearman?s correlation coefficient as appropriate. Strata will be compared by using the log-rank test. Multivariate models will be constructed by introducing all variables aforementioned simultaneously into the model and then eliminating variables using the backward selection method. P values will be two-tailed and considered significant at alpha 0.05. | Up to 3 years |
| False Discovery Rate (Correlative Companion Study- A091105-ST1 Study) | Permutation testing of the same selection will be performed 1000 times and the sample group labels switched around in each permutation. A two-sided t-test will be used to identify differentially expressed genes on log transformed data and those with a twofold change. False discovery rate will be assessed by permutation testing (n = 1000) of the sample group labels. Enrichment will be assessed by one-sided Fisher?s exact test with estimated false discovery rate. | Up to day 8 |
| Treatment-specific Gene Expression Signature (Correlative Companion Study- A091105-ST1 Study) | The analysis will identify over- and under-expressed genes in pre-treatment and day 8 biopsies as compared to all control samples. | Up to day 8 |
| Changes in Immunohistochemistry Score of Vascular Endothelial Growth Factor (Correlative Companion Study- A091105-ST1 Study) | Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test. | Baseline up to day 8 |
| Changes in Immunohistochemistry Score of Platelet-derived Growth Factor Receptor (Correlative Companion Study- A091105-ST1 Study) | Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test. | Baseline up to day 8 |
| Changes in Immunohistochemistry Score of Beta-catenin Cytoplasm/Nuclear Ratio (Correlative Companion Study- A091105-ST1 Study) | Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test. | Baseline up to day 8 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| PCR Oncology | Arroyo Grande | California | 93420 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| Christiana Gynecologic Oncology LLC | Newark | Delaware | 19713 | United States |
| Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | 19713 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware | 19973 | United States |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | 19801 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| John B Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Low Country Cancer Care | Savannah | Georgia | 31404 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii | 96817 | United States |
| Kuakini Medical Center | Honolulu | Hawaii | 96817 | United States |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | 96766 | United States |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | United States |
| Queen's Cancer Center - Pearlridge | ‘Aiea | Hawaii | 96701 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Reid Health | Richmond | Indiana | 47374 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | United States |
| Oncology Hematology Care Inc-Crestview | Crestview Hills | Kentucky | 41017 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | United States |
| Cox Cancer Center Branson | Branson | Missouri | 65616 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint Louis Cancer and Breast Institute-South City | St Louis | Missouri | 63109 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Nebraska Hematology and Oncology | Lincoln | Nebraska | 68506 | United States |
| Nebraska Cancer Research Center | Lincoln | Nebraska | 68510 | United States |
| Southeast Nebraska Cancer Center - 68th Street Place | Lincoln | Nebraska | 68516 | United States |
| Faith Regional Health Services Carson Cancer Center | Norfolk | Nebraska | 68701 | United States |
| Great Plains Health Callahan Cancer Center | North Platte | Nebraska | 69101 | United States |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Alegent Health Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Nebraska Cancer Specialists - Omaha | Omaha | Nebraska | 68124 | United States |
| Alegent Health Lakeside Hospital | Omaha | Nebraska | 68130 | United States |
| Oncology Hematology West PC | Omaha | Nebraska | 68130 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Regional West Medical Center Cancer Center | Scottsbluff | Nebraska | 69361 | United States |
| Cancer and Blood Specialists-Henderson | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | United States |
| Las Vegas Cancer Center-Henderson | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | 89074 | United States |
| GenesisCare USA - Henderson | Henderson | Nevada | 89074 | United States |
| Cancer and Blood Specialists-Shadow | Las Vegas | Nevada | 89106 | United States |
| Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | 89106 | United States |
| GenesisCare USA - Las Vegas | Las Vegas | Nevada | 89109 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada | 89109 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada | 89113 | United States |
| Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | 89119 | United States |
| Cancer Therapy and Integrative Medicine | Las Vegas | Nevada | 89121 | United States |
| Cancer and Blood Specialists-Tenaya | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | 89128 | United States |
| GenesisCare USA - Vegas Tenaya | Las Vegas | Nevada | 89128 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | 89144 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada | 89148-2405 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| GenesisCare USA - Fort Apache | Las Vegas | Nevada | 89148 | United States |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89148 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | Las Vegas | Nevada | 89149 | United States |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | United States |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89169 | United States |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | United States |
| Oncology Hematology Care Inc-Eden Park | Cincinnati | Ohio | 45202 | United States |
| Oncology Hematology Care Inc-Mercy West | Cincinnati | Ohio | 45211 | United States |
| Oncology Hematology Care Inc-Anderson | Cincinnati | Ohio | 45230 | United States |
| Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio | 45236 | United States |
| Oncology Hematology Care Inc-Blue Ash | Cincinnati | Ohio | 45242 | United States |
| Good Samaritan Hospital - Dayton | Dayton | Ohio | 45406 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | United States |
| Dayton NCI Community Oncology Research Program | Dayton | Ohio | 45459 | United States |
| Oncology Hematology Care Inc-Healthplex | Fairfield | Ohio | 45014 | United States |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | United States |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Springfield Regional Cancer Center | Springfield | Ohio | 45504 | United States |
| Springfield Regional Medical Center | Springfield | Ohio | 45505 | United States |
| Upper Valley Medical Center | Troy | Ohio | 45373 | United States |
| Wright-Patterson Medical Center | Wright-Patterson Air Force Base | Ohio | 45433 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | 74146 | United States |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| Sovah Health Martinsville | Martinsville | Virginia | 24115 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| 30575484 | Derived | Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. doi: 10.1056/NEJMoa1805052. |
| Crossed Over |
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| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Sorafenib Tosylate) | Patients receive sorafenib tosylate PO QD on days 1-28. |
| BG001 | Arm II (Placebo) | Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression. |
| BG002 | 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Progression-free Survival(PFS) Rate | PFS is defined as the time from randomization to the first occurrence of progression or death due to any cause. If no event exists, the PFS will be censored at the last disease assessment. Data following cross over will be analyzed and summarized separately from the data from the main course of treatment for these patients in an exploratory and hypothesis generating manner. Intention to treat principles will be used. Patient disease status was evaluated using RECSIT v1.1. Patients ending treatment for symptomatic deterioration without radiographic evidence of PD, were classified as having PD. Otherwise, patients not yet showing disease progression were classified as having no progression at the most recent disease assessment and in the following cases: crossing over to receive sorafenib, date of first non-protocol directed anti-cancer therapy, lost to follow-up, withdrawal of consent, and changing imaging methods from that which was used at study entry. | All patients that received treatment and were assessed for response. | Posted | Count of Participants | Participants | Time from randomization to the first occurrence of progression or death due to any cause, assessed up to 3 years |
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| Secondary | Incidence of Adverse Events, Using the Patient Reported Outcomes-Common Terminology Criteria in Adverse Events Version 4.0 | INCLUDED IN THE ADVERSE EVENTS PORTION OF THE RESULTS SECTION. Frequency tables, summary statistics, and categorical analysis will be used to compare the distributions of toxicity for patients treated with sorafenib tosylate vs placebo. Data for patients who have crossed over or having received surgical or radiotherapy intervention will be summarized independently from their primary course of study treatment in an exploratory and hypothesis generating manner. | Per protocol, crossover patients are excluded/censored from secondary analysis and endpoints. | Posted | Count of Participants | Participants | Up to 3 years |
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| Secondary | Time to Surgical Intervention During Treatment | A log rank test will be used to compare the distributions of time to surgical intervention between the two arms using a 2-sided test and alpha=0.05 level of significance. Kaplan-Meier methodology will be used to estimate various time points and 95% confidence intervals will be calculated for these estimates. Surgery will be classified by outcome (eg, complete-macroscopic, complete-microscopic, or partial), type, location (eg, limb), thereafter analyzed by categorical analysis and descriptive statistics. Non-parametric methods will be used, as appropriate. Too few patients had surgery during treatment to perform analysis. | Only the number of patients is presented due to the Protected Health Information as to the time to surgery for each of these individual patients. Crossover patients are per protocol, excluded/censored from secondary analysis and endpoints. | Posted | Count of Participants | Participants | Time between randomization to the patient undergoing therapeutic surgical resection for this disease, assessed up to 3 years |
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| Secondary | Overall Survival | Kaplan-Meier methodology and log rank tests will be used to compare overall survival between the groups at various time points (eg, 1 year rate, 2 year rate, etc) and 95% confidence intervals will be calculated for these estimates. Data following crossover will be analyzed and summarized separately from the main course of treatment for these patients in an exploratory and hypothesis generating manner. | All patients that started treatment and were assessed for survival. Crossover patients were excluded/censored from secondary analysis and endpoints. | Posted | Count of Participants | Participants | Time between the date of randomization to until death, assessed up to 3 years |
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| Secondary | Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1 | Compared between the two treatment arms and using the Cochran-Mantel-Haenszel test. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. Patients on Arm II (placebo) who crossover are censored for Best Objective Status at the time of crossover. | All patients that started treatment and were assessed for response. | Posted | Count of Participants | Participants | Up to 3 years |
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| Secondary | Duration of Response | Kaplan Meier methodology will be used to estimate the distribution of duration of response and the log-rank test will be used to test for a difference in duration of response between the two arms. Patients on Arm II (placebo) who crossover are censored for Duration of Response at the time of crossover. | All patients that started treatment and were assessed for response. | Posted | Median | Inter-Quartile Range | Months | Time between first tumor response and progression, assessed up to 3 years |
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| Other Pre-specified | Percent Change in Tumor Size by Response Evaluation Criteria in Solid Tumors Version 1.1 (Correlative Companion Study-Imaging Study) | Best response (ordinal variable) and percent T2 signal change (continuous) will be correlated by Spearman?s rho. | Not Posted | Baseline up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Changes in MRI T2 Signal (Correlative Companion Study-Imaging Study) | Percent T2 signal change (continuous) will be correlated by Spearman?s rho. The percent changes in MRI T2 signal from Week 8 to subsequent imaging will be compared between groups with > 30% pain palliation using t-test or a nonparametric alternative (e.g., Wilcoxon rank-sum test). | Not Posted | Baseline up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Pain Progression Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study- A091105-H01 QOL Study) | Defined as a >= 30% increase compared with baseline in the worst pain intensity score (BPI-SF ?worst pain? item) or either a >= 30% increase in the average daily use of any type of opioid narcotic or the addition of a new opioid narcotic compared with baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. | Not Posted | Date of randomization to the earliest date that pain progression is observed, assessed up to 12 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study-A091105-H01 QOL Study) | Defined at each time point as >= 30% decrease from baseline in the worst pain intensity score (BPI-SF ?worst pain? item), with neither a concomitant >= 30% increase in average daily use of any opioid narcotic, nor addition of any new opioid narcotic, relative to baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. | Not Posted | Date of randomization to the earliest date that confirmed pain palliation is observed, assessed up to 12 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Duration of Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study- A091105-H01 QOL Study) | Defined for all patients who experience confirmed pain palliation. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group. | Not Posted | Time from the earliest date that confirmed pain palliation is observed to the earliest date that pain progression is observed, assessed up to 12 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study-A091105-H01 QOL Study) | Rate of pain palliation at week 8 confirmed as week 12 will be compared between arms using a two-sided alpha=0.05 chi-squared tests at the time of the final analysis. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group. | Not Posted | Baseline up to 12 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cadherin-associated Protein, Beta 1 (CTNNB1) Genotype (Correlative Companion Study-A091105-ST1 Study) | Associations among the possible predictors of response to sorafenib and CTNNBI mutations will be examined using Fisher?s exact test, Kruskal-Wallis test, or Spearman?s correlation coefficient as appropriate. Strata will be compared by using the log-rank test. Multivariate models will be constructed by introducing all variables aforementioned simultaneously into the model and then eliminating variables using the backward selection method. P values will be two-tailed and considered significant at alpha 0.05. | Not Posted | Up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | False Discovery Rate (Correlative Companion Study- A091105-ST1 Study) | Permutation testing of the same selection will be performed 1000 times and the sample group labels switched around in each permutation. A two-sided t-test will be used to identify differentially expressed genes on log transformed data and those with a twofold change. False discovery rate will be assessed by permutation testing (n = 1000) of the sample group labels. Enrichment will be assessed by one-sided Fisher?s exact test with estimated false discovery rate. | Not Posted | Up to day 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Treatment-specific Gene Expression Signature (Correlative Companion Study- A091105-ST1 Study) | The analysis will identify over- and under-expressed genes in pre-treatment and day 8 biopsies as compared to all control samples. | Not Posted | Up to day 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Changes in Immunohistochemistry Score of Vascular Endothelial Growth Factor (Correlative Companion Study- A091105-ST1 Study) | Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test. | Not Posted | Baseline up to day 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Changes in Immunohistochemistry Score of Platelet-derived Growth Factor Receptor (Correlative Companion Study- A091105-ST1 Study) | Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test. | Not Posted | Baseline up to day 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Changes in Immunohistochemistry Score of Beta-catenin Cytoplasm/Nuclear Ratio (Correlative Companion Study- A091105-ST1 Study) | Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test. | Not Posted | Baseline up to day 8 | Participants |
Up to 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Sorafenib Tosylate) | Patients receive sorafenib tosylate PO QD on days 1-28. | 1 | 49 | 11 | 49 | 49 | 49 |
| EG001 | Arm II (Placebo) | Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression. | 0 | 36 | 6 | 36 | 34 | 36 |
| EG002 | Crossover Group | Upon disease progression, patients treated with placebo will be allowed to crossover to the open label sorafenib arm. | 0 | 28 | 5 | 28 | 27 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pregnancy, puerperium and perinatal conditions - Other, specify | Pregnancy, puerperium and perinatal conditions | MedDRA 12 | Systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Endocrine disorders - Other, specify | Endocrine disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 12 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | MedDRA 12 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Cholesterol high | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Hemoglobin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12 | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12 | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Phantom pain | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Spasticity | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | MedDRA 12 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrinal Murugesan Gounder M.D. | Memorial Sloan-Kettering Cancer Center | 646-888-4167 | gounderm@mskcc.org |
| Mar 19, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018222 | Desmoid Tumors |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Crossover Patients |
After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints. |
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