Trial · NCT02048722
Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
NCT02048722, Phase 2, Completed, Northwestern University; results first posted 2020-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma. Trials, record NCT02048722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02048722
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- NCT number
- NCT02048722
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Adult Angiosarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- regorafenib
- First posted
- 2014-01-29
- Last updated
- 2022-04-25
- Results first posted
- 2020-07-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) at 4 Months | At 4 months (of treatment) | The progression-free survival (PFS) at 4 months will be defined as the number of patients with progression absent at 4 months divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first and will be estimated using Kaplan-Meier methods and reported as a survival probability. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD. |
| Secondary | Progression-Free Survival (PFS) at 3 and 6 Months | Assessed at 3 months and 6 months | The progression-free survival (PFS) at 3 and 6 months will be defined as the number of patients with progression absent at 3 months and 6 months divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first and will be estimated using Kaplan-Meier methods and reported as a survival probability. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD. |
| Secondary | Median Progression-free Survival (PFS) | The duration of time from start of treatment until time of progression, up to 5 years | The median progression-free rate (PFR) will be defined as the number of patients with progression absent divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first for up to 5 years and will be estimated using Kaplan-Meier methods. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD. |
| Secondary | Overall Survival | From start of treatment up to 5 years | Overall survival will be defined as the time from start of treatment until death from any cause and will be estimated using Kaplan-Meier methods and reported as a survival probability. Patients that are alive at the time of data analysis will be censored at the date of known survival status. |
| Secondary | Response Rate | At baseline and after every 2 cycles, up to 12 cycles where one cycle is 28 days | Imaging (such as a CT scan) will be done at baseline (within 4 weeks before the first dose) then after every 2 cycles while on treatment for tumor response evaluation. Response will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Best response of each patient will be used and responses will be defined as the following: Complete response (CR): Disappearance of all target lesions Partial response (PR): \> 30% decrease in the baseline sum diameters of target lesions |
| Secondary | Rate of Tumor Control | At baseline and after every 2 cycles, up to 12 cycles where one cycle is 28 days | Imaging will be used at baseline then after every 2 cycles while on treatment to measure tumor size and response to treatment, the data collected from all patients on study will be used to calculate the rate and duration of tumor control. Response will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Response and stable disease will be defined as the following: Complete response (CR): Disappearance of all target lesions Partial response (PR): \> 30% decrease in the baseline sum diameters of target lesions Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
| Secondary | Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0) | From treatment initiation though 30 days post the last treatment for a max of 12 cycles where one cycle is 28 days | Overall worst grade related toxicity (number of patients) was collected from the start of treatment until 30 days post the last treatment where patients were treated until progressive disease or unacceptable toxicity or patient withdrawal of treatment. All Adverse events that were determined to be at least possibly related to treatment are reported. All adverse events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The severity of an AE is graded as follows: Mild (grade 1): the event causes discomfort without disruption of normal daily activities. Moderate (grade 2): the event causes discomfort that affects normal daily activities. Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Life-threatening (grade 4): the patient was at risk of death at the time of the event. Fatal (grade 5): the event caused death |
Source ClinicalTrials.gov
Outcomes7
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) at 4 Months | At 4 months (of treatment) | 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or cycle 1 or Cycle 1: follow up missing from the dataset at the time of the analysis. | percentage of patients alive | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) at 3 and 6 Months | Assessed at 3 months and 6 months | 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or cycle 1 or Cycle 1: follow up missing from the dataset at the time of the analysis. | percentage patients alive | NUMBER |
| SECONDARY | Median Progression-free Survival (PFS) | The duration of time from start of treatment until time of progression, up to 5 years | 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or cycle 1 or Cycle 1: follow up missing from the dataset at the time of the analysis. | months | MEDIAN |
| SECONDARY | Overall Survival | From start of treatment up to 5 years | 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or cycle 1 or Cycle 1: follow up missing from the dataset at the time of the analysis. | months | MEDIAN |
| SECONDARY | Response Rate | At baseline and after every 2 cycles, up to 12 cycles where one cycle is 28 days | 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or cycle 1 or Cycle 1: follow up missing from the dataset at the time of the analysis. | participants | NUMBER |
| SECONDARY | Rate of Tumor Control | At baseline and after every 2 cycles, up to 12 cycles where one cycle is 28 days | 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or cycle 1 or Cycle 1: follow up missing from the dataset at the time of the analysis. | patients | NUMBER |
| SECONDARY | Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0) | From treatment initiation though 30 days post the last treatment for a max of 12 cycles where one cycle is 28 days | At the time of data pull (12/02/2019) for this outcome measure two patients remained on treatment. Any subsequent AEs determined to be related to treatment for these patients is not included here. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group95
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) at 4 Months | Treatment (Regorafenib) | 52.17 | 95% Confidence Interval 35.28 to 77.16 | percentage of patients alive | |
| Progression-Free Survival (PFS) at 3 and 6 Months | Treatment (Regorafenib) | 3 months | 56.52 | 95% Confidence Interval 39.5 to 80.89 | percentage patients alive |
| Progression-Free Survival (PFS) at 3 and 6 Months | Treatment (Regorafenib) | 6 months | 47.83 | 95% Confidence Interval 31.21 to 73.29 | percentage patients alive |
| Median Progression-free Survival (PFS) | Treatment (Regorafenib) | 5.49 | 95% Confidence Interval 1.84 to 9.53 | months | |
| Overall Survival | Treatment (Regorafenib) | 14.06 | 95% Confidence Interval 9.76 to 22.24 | months | |
| Response Rate | Treatment (Regorafenib) | Complete Response | 2 | participants | |
| Response Rate | Treatment (Regorafenib) | Partial Response | 2 | participants | |
| Rate of Tumor Control | Treatment (Regorafenib) | Complete Response | 2 | patients | |
| Rate of Tumor Control | Treatment (Regorafenib) | Partial Response | 2 | patients | |
| Rate of Tumor Control | Treatment (Regorafenib) | Stable Disease | 9 | patients |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 results by groupParticipant flow13
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 2 Cycles of Treatment | STARTED | Treatment (Regorafenib) | 31 | |
| 2 Cycles of Treatment | Attempted 1st Cycle | Treatment (Regorafenib) | 31 | |
| 2 Cycles of Treatment | Attempted 2nd Cycle | Treatment (Regorafenib) | 23 | |
| 2 Cycles of Treatment | COMPLETED | Treatment (Regorafenib) | 23 | |
| 2 Cycles of Treatment | NOT COMPLETED | Treatment (Regorafenib) | 8 | |
| Reached 1st Response/Continued Treatment | STARTED | Treatment (Regorafenib) | 23 | |
| Reached 1st Response/Continued Treatment | Assessed for First Response | Treatment (Regorafenib) | 23 | |
| Reached 1st Response/Continued Treatment | Went on to Cycle 3 and Beyond | Treatment (Regorafenib) | 13 | |
| Reached 1st Response/Continued Treatment | COMPLETED | Treatment (Regorafenib) | 13 | |
| Reached 1st Response/Continued Treatment | NOT COMPLETED | Treatment (Regorafenib) | 10 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 participant flowAdverse events148
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 | Treatment (Regorafenib) | 14 | 31 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Treatment (Regorafenib) | 2 | 31 | |
| other | Chest pain - cardiac | Cardiac disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Myocardial infarction | Cardiac disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Ear pain | Ear and labyrinth disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Tinnitus | Ear and labyrinth disorders | Treatment (Regorafenib) | 1 | 31 | |
| other | Hypothyroidism | Endocrine disorders | Treatment (Regorafenib) | 1 | 31 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Regorafenib) | 24 | 31 |
| Total, other adverse events | Treatment (Regorafenib) | 31 | 31 |
| Total, serious adverse events | Treatment (Regorafenib) | 15 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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