Trial · NCT02048371
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
NCT02048371, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes. Trials, record NCT02048371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02048371
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
- NCT number
- NCT02048371
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Liposarcoma, Osteogenic Sarcoma, Ewing/Ewing-like Sarcoma, Rhabdomyosarcoma, Mesenchymal Chondrosarcoma
- Interventions
- Regorafenib, Placebo
- First posted
- 2014-01-29
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS). Cohort A and Cohort B | up to 3 years | 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. |
| Primary | Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E | up to 16 weeks | 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. |
| Secondary | The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts. | up to 3 years | 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. |
| Secondary | Overall Response Rate (ORR). All Cohorts. | up to 3 years | 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 |
| Secondary | Progression-free Survival (PFS), Cohorts A and B, After Crossover. | up to 3 years | 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. |
| Secondary | Response Rate (RR), Cohorts A and B, After Crossover. | up to 3 years | The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment. |
| Secondary | Time to Tumor Progression (TTP), Cohorts A and B, After Crossover. | up to 3 years | 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. |
| Secondary | Overall Survival (OS). Cohorts A and B, After Crossover. | up to 3 years | 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. |
| Secondary | Disease Specific Survival (DSS). Cohorts A and B, After Crossover. | up to 3 years | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS). Cohort A and Cohort B | up to 3 years | months | MEDIAN | |
| PRIMARY | Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E | up to 16 weeks | months | MEDIAN | |
| SECONDARY | The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts. | up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate (ORR). All Cohorts. | up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS), Cohorts A and B, After Crossover. | up to 3 years | Participants who started on placebo in Cohorts A and B, then crossed over to active drug after progression. | months | MEDIAN |
| SECONDARY | Response Rate (RR), Cohorts A and B, After Crossover. | up to 3 years | Participants who started on placebo then crossed over to active drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Tumor Progression (TTP), Cohorts A and B, After Crossover. | up to 3 years | Participants who crossed over to active drug after placebo. | months | MEDIAN |
| SECONDARY | Overall Survival (OS). Cohorts A and B, After Crossover. | up to 3 years | Participants who started on placebo and crossed over to active drug after progression. | months | MEDIAN |
| SECONDARY | Disease Specific Survival (DSS). Cohorts A and B, After Crossover. | up to 3 years | Participants who started on placebo and crossed over to active drug upon progression. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS). Cohort A and Cohort B | Cohort A: Liposarcoma | 1.87 | 95% Confidence Interval 0.92 to 3.67 | months | |
| Progression-free Survival (PFS). Cohort A and Cohort B | Cohort A: Liposarcoma, Placebo | 2.07 | 95% Confidence Interval 1.64 to 3.44 | months | |
| Progression-free Survival (PFS). Cohort A and Cohort B | Cohort B: Osteosarcoma | 3.6 | 95% Confidence Interval 2.0 to 7.6 | months | |
| Progression-free Survival (PFS). Cohort A and Cohort B | Cohort B: Osteosarcoma, Placebo | 1.7 | 95% Confidence Interval 1.2 to 1.8 | months | |
| Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E | Cohort C: Ewing Sarcoma | 3.4 | 95% Confidence Interval 1.7 to 3.7 | months | |
| Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E | Cohort D: Rhabdomyosarcoma | 1.82 | 95% Confidence Interval 1.58 to NA | months | |
| Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E | Cohort E: Mesenchymal Chondrosarcoma | NA | 95% Confidence Interval NA to NA | months | |
| The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts. | Cohort A: Liposarcoma | 12 | Participants | ||
| The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts. | Cohort A: Liposarcoma, Placebo | 15 | Participants | ||
| The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts. | Cohort B: Osteosarcoma | 6 | Participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Liposarcoma | 24 | |
| Overall Study | STARTED | Cohort A: Liposarcoma, Placebo | 9 | |
| Overall Study | STARTED | Cohort A: Liposarcoma Crossover | 15 | |
| Overall Study | STARTED | Cohort B: Osteosarcoma | 22 | |
| Overall Study | STARTED | Cohort B: Osteosarcoma, Placebo | 9 | |
| Overall Study | STARTED | Cohort B: Osteosarcoma Crossover | 11 | |
| Overall Study | STARTED | Cohort C: Ewing Sarcoma | 30 | |
| Overall Study | STARTED | Cohort D: Rhabdomyosarcoma | 10 | |
| Overall Study | STARTED | Cohort E: Mesenchymal Chondrosarcoma | 1 | |
| Overall Study | COMPLETED | Cohort A: Liposarcoma | 17 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,008
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort A: Liposarcoma | 0 | 39 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort A: Liposarcoma, Placebo | 0 | 9 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B: Osteosarcoma | 0 | 33 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B: Osteosarcoma, Placebo | 1 | 9 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort C: Ewing Sarcoma | 0 | 30 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort D: Rhabdomyosarcoma | 0 | 6 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort D: Pediatric | 0 | 4 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort E: Mesenchymal Chondrosarcoma | 0 | 1 | 0 |
| other | Hypertension | Blood and lymphatic system disorders | Cohort A: Liposarcoma | 0 | 39 | 0 |
| other | Hypertension | Blood and lymphatic system disorders | Cohort A: Liposarcoma, Placebo | 0 | 9 | 0 |
1 to 10 of 1,008Source ClinicalTrials.gov
See all 1,008 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Liposarcoma | 25 | 39 |
| Total, all-cause mortality | Cohort A: Liposarcoma, Placebo | 7 | 9 |
| Total, all-cause mortality | Cohort B: Osteosarcoma | 26 | 33 |
| Total, all-cause mortality | Cohort B: Osteosarcoma, Placebo | 8 | 9 |
| Total, all-cause mortality | Cohort C: Ewing Sarcoma | 17 | 30 |
| Total, all-cause mortality | Cohort D: Rhabdomyosarcoma | 4 | 6 |
| Total, all-cause mortality | Cohort D: Pediatric | 2 | 4 |
| Total, all-cause mortality | Cohort E: Mesenchymal Chondrosarcoma | 0 | 1 |
| Total, other adverse events | Cohort A: Liposarcoma | 26 | 39 |
| Total, other adverse events | Cohort A: Liposarcoma, Placebo | 8 | 9 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort A: Liposarcoma Crossover vs Cohort B: Osteosarcoma Crossover: Response Rate (RR), Cohorts A and B, After Crossover. |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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