A Phase 2 interventional study of Regorafenib and Placebo in Liposarcoma, Osteogenic Sarcoma and Ewing/Ewing-like Sarcoma, sponsored by Sarcoma Alliance for Research through Collaboration. Completed at 18 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Sarcoma Alliance for Research through Collaboration · Phase 2, Interventional, and Treatment
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma.
Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma.
Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents
160 studies on the registry are indexed under Liposarcoma; 36 are open to participants now.
This study's enrollment of 131 is above the median of 52 across 136 interventional studies indexed under Liposarcoma.
Browse Liposarcoma studies →Sarcoma Alliance for Research through Collaboration is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Drug: Regorafenib
21 days on and 7 days off Placebo
Drug: Placebo
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Drug: Regorafenib
21 days on and 7 days off Placebo
Drug: Placebo
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Drug: Regorafenib
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Drug: Regorafenib
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Drug: Regorafenib
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
21 days on and 7 days off
Progression-free Survival (PFS). Cohort A and Cohort B
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: up to 3 years
Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.
Time frame: up to 16 weeks
The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts.
Common Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.
Time frame: up to 3 years
Overall Response Rate (ORR). All Cohorts.
The overall response rate (ORR) is the percentage of patients whose cancer shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1
Time frame: up to 3 years
Progression-free Survival (PFS), Cohorts A and B, After Crossover.
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time frame: up to 3 years
Response Rate (RR), Cohorts A and B, After Crossover.
The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.
Time frame: up to 3 years
Time to Tumor Progression (TTP), Cohorts A and B, After Crossover.
Time to tumor progression (TTP) is the length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.
Time frame: up to 3 years
Overall Survival (OS). Cohorts A and B, After Crossover.
Overall survival (OS) is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Time frame: up to 3 years
Disease Specific Survival (DSS). Cohorts A and B, After Crossover.
Disease-specific survival refers to the percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time.
Time frame: up to 3 years
| Milestone | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort A: Liposarcoma Crossover | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort B: Osteosarcoma Crossover | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma |
|---|---|---|---|---|---|---|---|---|---|
| Started | 24 | 9 | 15 | 22 | 9 | 11 | 30 | 10 | 1 |
| Completed | 17 | 1 | 9 | 11 | 3 | 8 | 22 | 6 | 1 |
| Not completed | 7 | 8 | 6 | 11 | 6 | 3 | 8 | 4 | 0 |
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| months | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo |
|---|---|---|---|---|
| Progression-free Survival (PFS). Cohort A and Cohort B | 1.87 (0.92 to 3.67) | 2.07 (1.64 to 3.44) | 3.6 (2.0 to 7.6) | 1.7 (1.2 to 1.8) |
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.
| months | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma |
|---|---|---|---|
| Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E | 3.4 (1.7 to 3.7) | 1.82 (1.58 to NA) | NA (NA to NA) |
Common Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.
| Participants | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma |
|---|---|---|---|---|---|---|---|
| The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts. | 12 | 15 | 6 | 9 | 6 | 2 | 0 |
The overall response rate (ORR) is the percentage of patients whose cancer shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1
| Participants | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma |
|---|---|---|---|---|---|---|---|
| Overall Response Rate (ORR). All Cohorts. | 0 | 1 | 3 | 0 | 3 | 0 | 0 |
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
| months | Cohort A: Liposarcoma Crossover | Cohort B: Osteosarcoma Crossover |
|---|---|---|
| Progression-free Survival (PFS), Cohorts A and B, After Crossover. | 1.68 (0.92 to 5.59) | 5.78 (3.55 to NA) |
The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.
| Participants | Cohort A: Liposarcoma Crossover | Cohort B: Osteosarcoma Crossover |
|---|---|---|
| Response Rate (RR), Cohorts A and B, After Crossover. | 0 | 0 |
Time to tumor progression (TTP) is the length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.
| months | Cohort A: Liposarcoma Crossover | Cohort B: Osteosarcoma Crossover |
|---|---|---|
| Time to Tumor Progression (TTP), Cohorts A and B, After Crossover. | 1.76 (0.92 to NA) | 5.78 (3.55 to NA) |
Overall survival (OS) is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
| months | Cohort A: Liposarcoma Crossover | Cohort B: Osteosarcoma Crossover |
|---|---|---|
| Overall Survival (OS). Cohorts A and B, After Crossover. | 7.98 (3.98 to NA) | 16.11 (8.54 to NA) |
Disease-specific survival refers to the percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time.
| months | Cohort A: Liposarcoma Crossover | Cohort B: Osteosarcoma Crossover |
|---|---|---|
| Disease Specific Survival (DSS). Cohorts A and B, After Crossover. | 7.98 (3.98 to NA) | 16.11 (8.54 to NA) |
Collected over Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Liposarcoma | 25/39 (64.1%) | 28/39 (71.8%) | 26/39 (66.7%) |
| Cohort A: Liposarcoma, Placebo | 7/9 (77.8%) | 7/9 (77.8%) | 8/9 (88.9%) |
| Cohort B: Osteosarcoma | 26/33 (78.8%) | 24/33 (72.7%) | 26/33 (78.8%) |
| Cohort B: Osteosarcoma, Placebo | 8/9 (88.9%) | 7/9 (77.8%) | 6/9 (66.7%) |
| Cohort C: Ewing Sarcoma | 17/30 (56.7%) | 21/30 (70%) | 22/30 (73.3%) |
| Cohort D: Rhabdomyosarcoma | 4/6 (66.7%) | 4/6 (66.7%) | 2/6 (33.3%) |
| Cohort D: Pediatric | 2/4 (50%) | 2/4 (50%) | 1/4 (25%) |
| Cohort E: Mesenchymal Chondrosarcoma | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort D: Pediatric | Cohort E: Mesenchymal Chondrosarcoma |
|---|---|---|---|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 4/39 | 3/9 | 0/33 | 1/9 | 0/30 | 1/6 | 0/4 | 0/1 |
| HyperfibrinolysisBlood and lymphatic system disorders | 0/39 | 0/9 | 0/33 | 0/9 | 0/30 | 2/6 | 0/4 | 0/1 |
| PainGeneral disorders | 2/39 | 1/9 | 0/33 | 0/9 | 2/30 | 2/6 | 0/4 | 0/1 |
| HypophosphatemiaInvestigations | 3/39 | 2/9 | 5/33 | 0/9 | 9/30 | 1/6 | 0/4 | 0/1 |
| VomitingGastrointestinal disorders | 1/39 | 0/9 | 0/33 | 1/9 | 0/30 | 1/6 | 1/4 | 0/1 |
| Lymphocyte Count DecreasedInvestigations | 2/39 | 1/9 | 1/33 | 0/9 | 0/30 | 1/6 | 1/4 | 0/1 |
| Alanine Aminotransferase IncreasedInvestigations | 0/39 | 0/9 | 1/33 | 0/9 | 1/30 | 0/6 | 1/4 | 0/1 |
| Platelet Count DecreasedInvestigations | 0/39 | 0/9 | 2/33 | 0/9 | 0/30 | 1/6 | 1/4 | 0/1 |
| Neutrophil Count DecreasedInvestigations | 0/39 | 0/9 | 0/33 | 0/9 | 1/30 | 0/6 | 1/4 | 0/1 |
| White Blood Cell DecreasedInvestigations | 0/39 | 0/9 | 0/33 | 0/9 | 1/30 | 0/6 | 1/4 | 0/1 |
| Event | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort D: Pediatric | Cohort E: Mesenchymal Chondrosarcoma |
|---|---|---|---|---|---|---|---|---|
| HypertensionVascular disorders | 6/39 | 4/9 | 5/33 | 5/9 | 5/30 | 2/6 | 0/4 | 0/1 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 7/39 | 0/9 | 9/33 | 0/9 | 10/30 | 0/6 | 1/4 | 0/1 |
| HypertensionBlood and lymphatic system disorders | 0/39 | 0/9 | 10/33 | 1/9 | 0/30 | 0/6 | 0/4 | 0/1 |
| Alkaline Phosphatase ElevatedEndocrine disorders | 0/39 | 0/9 | 2/33 | 2/9 | 0/30 | 0/6 | 0/4 | 0/1 |
| DiarrheaGastrointestinal disorders | 0/39 | 2/9 | 3/33 | 0/9 | 5/30 | 0/6 | 0/4 | 0/1 |
| NauseaGastrointestinal disorders | 3/39 | 0/9 | 6/33 | 2/9 | 6/30 | 0/6 | 0/4 | 0/1 |
| FatigueGeneral disorders | 3/39 | 2/9 | 3/33 | 1/9 | 3/30 | 0/6 | 0/4 | 0/1 |
| FeverGeneral disorders | 0/39 | 2/9 | 3/33 | 0/9 | 1/30 | 0/6 | 0/4 | 0/1 |
| HypoalbuminemiaMetabolism and nutrition disorders | 0/39 | 2/9 | 0/33 | 1/9 | 0/30 | 0/6 | 0/4 | 0/1 |
| HeadacheNervous system disorders | 0/39 | 0/9 | 0/33 | 1/9 | 6/30 | 0/6 | 0/4 | 0/1 |
| Age, Categorical(Participants) | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 4 |
| Between 18 and 65 years | 17 | 12 | 21 | 16 | 29 | 6 | 1 | 102 |
| >=65 years | 7 | 12 | 1 | 4 | 1 | 0 | 0 | 25 |
| Sex: Female, Male(Participants) | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 14 | 6 | 16 | 6 | 10 | 5 | 0 | 57 |
| Male | 10 | 18 | 6 | 14 | 20 | 5 | 1 | 74 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 4 | 2 | 1 | 2 | 0 | 10 |
| Not Hispanic or Latino | 23 | 22 | 17 | 17 | 28 | 6 | 1 | 114 |
| Unknown or Not Reported | 1 | 1 | 1 | 1 | 1 | 2 | 0 | 7 |
| Race (NIH/OMB)(Participants) | Cohort A: Liposarcoma | Cohort A: Liposarcoma, Placebo | Cohort B: Osteosarcoma | Cohort B: Osteosarcoma, Placebo | Cohort C: Ewing Sarcoma | Cohort D: Rhabdomyosarcoma | Cohort E: Mesenchymal Chondrosarcoma | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Asian | 0 | 3 | 2 | 3 | 2 | 1 | 0 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 5 | 1 | 5 | 0 | 0 | 0 | 0 | 11 |
| White | 16 | 20 | 12 | 15 | 27 | 8 | 1 | 99 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 | 1 | 1 | 1 | 0 | 7 |
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Studies of the drug tested here: Regorafenib
Sarcoma Alliance for Research through Collaboration