Trial · NCT01391962
Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
NCT01391962, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sunitinib or Cediranib for Alveolar Soft Part Sarcoma. Trials, record NCT01391962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01391962
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
- NCT number
- NCT01391962
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Sarcoma, Alveolar Soft Part
- Interventions
- Cediranib, Sunitinib, Prochlorperazine, Promethazine, Benzodiazepine, Filgrastim, Sargramostim, Lomotil, Loperamide, Vitamin B6, Aquaphor, Acetaminophen, Levothyroxine, Warfarin
- First posted
- 2011-07-12
- Last updated
- 2026-02-02
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Time on treatment (an average of 497 days or 16 months) | Objective response rate is the combined partial and complete response rate, with those terms defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. |
| Primary | Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Time on treatment (an average of 497 days or 16 months) | Objective response rate is the combined partial and complete response rate, with those terms defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. |
| Primary | Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I | Time on treatment (an average of 497 days or 16 months) | Objective response rate is the combined partial and complete response rate, with those terms defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. |
| Primary | Part II: Objective Response Rate (ORR) of Cediranib in Participants Who Progress on the Sunitinib Arm During Part I | Time on treatment (an average of 497 days or 16 months) | Objective response rate is the combined partial and complete response rate, with those terms defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. |
| Secondary | Maximum Observed Plasma Concentration of Cediranib | Before first dose on Cycle 1 day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 28 days) | Pharmacokinetic analysis was performed on blood samples from participants on cediranib (both upfront therapy and following cross-over). Human plasma samples were analyzed using a validated liquid chromatography-mass spectrometry (LC-MS) method and the maximum observed analyte concentration in plasma will be reported. No sampling or analysis will be done for participants receiving sunitinib. |
| Secondary | Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks for Participants Receiving Single-agent Cediranib and Single-agent Sunitinib Malate in Participants With Advanced ASPS During Part I | 24 weeks | 24-week PFS is defined as the probability of participants remaining alive and progression-free at 24 weeks after the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Secondary | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, an average of 523 days | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed | Time on treatment (an average of 497 days or 16 months) | Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. Progression is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. |
| Other | Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks During Part I for Participants Who Were Not Newly Diagnosed | 24 weeks | 24-week PFS is defined as the probability of patients remaining alive and progression-free at 24 weeks after the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Other | Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed | Time on treatment (an average of 497 days or 16 months) | Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. Progression is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Time on treatment (an average of 497 days or 16 months) | A total of 15/34 participants were analyzed: 15/16 participants who received cediranib in Part I were analyzed (1 participant was not evaluable for response). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Time on treatment (an average of 497 days or 16 months) | A total of 14/34 participants were analyzed: 14/18 participants who received sunitinib in Part I were analyzed (4 participants who received sunitinib were not evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I | Time on treatment (an average of 497 days or 16 months) | A total of 9/34 participants were analyzed: 9/9 participants who received sunitinib in Part II were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part II: Objective Response Rate (ORR) of Cediranib in Participants Who Progress on the Sunitinib Arm During Part I | Time on treatment (an average of 497 days or 16 months) | A total of 10/34 participants were analyzed: 10/13 participants who received cediranib in Part II were analyzed (3 participants were not evaluable for response). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration of Cediranib | Before first dose on Cycle 1 day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 28 days) | A total of 15/34 participants were analyzed: 15/29 participants who received cediranib in either Part I or Part II were analyzed. | Nanomolar | MEAN |
| SECONDARY | Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks for Participants Receiving Single-agent Cediranib and Single-agent Sunitinib Malate in Participants With Advanced ASPS During Part I | 24 weeks | Percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, an average of 523 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed | Time on treatment (an average of 497 days or 16 months) | A total of 11/34 participants were analyzed: of the 14 participants who were not newly diagnosed, 2 participants randomized to receive sunitinib and 1 participant randomized to receive cediranib in Part I were not evaluable for response, leaving only 11 reportable participants. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks During Part I for Participants Who Were Not Newly Diagnosed | 24 weeks | A total of 14/34 participants were analyzed. 20 participants not analyzed were newly diagnosed. The outcome is for non-newly diagnosed participants only. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed | Time on treatment (an average of 497 days or 16 months) | A total of 10/34 participants were analyzed: of the 11 participants who were not newly diagnosed and participated in Part II of the trial, 1 participant (who was randomized to receive sunitinib in Part I and then crossed over to receive cediranib in Part II) was not evaluable for response, leaving only 10 reportable participants. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | AZD2171 (Cediranib) 30 mg | Complete Response | 0 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | Complete Response | 0 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | AZD2171 (Cediranib) 30 mg | Partial Response | 0 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | Partial Response | 1 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Sunitinib Malate 37.5 mg | Complete Response | 0 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg | Complete Response | 0 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Sunitinib Malate 37.5 mg | Partial Response | 0 | Participants | |
| Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) | Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg | Partial Response | 1 | Participants | |
| Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | Complete Response | 0 | Participants | |
| Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | Partial Response | 0 | Participants |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow52
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I | STARTED | AZD2171 (Cediranib) 30 mg | 7 | |
| Part I | STARTED | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | 9 | |
| Part I | STARTED | Sunitinib Malate 37.5 mg | 5 | |
| Part I | STARTED | Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg | 13 | |
| Part I | Restaging | AZD2171 (Cediranib) 30 mg | 6 | |
| Part I | Restaging | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | 9 | |
| Part I | Restaging | Sunitinib Malate 37.5 mg | 4 | |
| Part I | Restaging | Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg | 12 | |
| Part I | Pharmacokinetic sampling | AZD2171 (Cediranib) 30 mg | 2 | |
| Part I | Pharmacokinetic sampling | AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg | 6 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 participant flowAdverse events448
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 | Abdominal pain | Gastrointestinal disorders | AZD2171 (Cediranib) 30 mg | 13 | 29 | 20 |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib Malate 37.5 mg | 3 | 27 | 3 |
| other | Alanine aminotransferase increased | Investigations | AZD2171 (Cediranib) 30 mg | 12 | 29 | 20 |
| other | Alanine aminotransferase increased | Investigations | Sunitinib Malate 37.5 mg | 11 | 27 | 22 |
| other | Alkaline phosphatase increased | Investigations | AZD2171 (Cediranib) 30 mg | 7 | 29 | 8 |
| other | Alkaline phosphatase increased | Investigations | Sunitinib Malate 37.5 mg | 4 | 27 | 6 |
| other | Allergic reaction | Immune system disorders | AZD2171 (Cediranib) 30 mg | 0 | 29 | 0 |
| other | Allergic reaction | Immune system disorders | Sunitinib Malate 37.5 mg | 2 | 27 | 2 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | AZD2171 (Cediranib) 30 mg | 4 | 29 | 4 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Sunitinib Malate 37.5 mg | 2 | 27 | 3 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD2171 (Cediranib) 30 mg | 0 | 29 |
| Total, all-cause mortality | Sunitinib Malate 37.5 mg | 1 | 27 |
| Total, other adverse events | AZD2171 (Cediranib) 30 mg | 28 | 29 |
| Total, other adverse events | Sunitinib Malate 37.5 mg | 26 | 27 |
| Total, serious adverse events | AZD2171 (Cediranib) 30 mg | 7 | 29 |
| Total, serious adverse events | Sunitinib Malate 37.5 mg | 7 | 27 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AZD2171 (Cediranib) 30 mg vs Sunitinib Malate 37.5 mg: deaths from any cause | Trial comparisons |
| AZD2171 (Cediranib) 30 mg vs Sunitinib Malate 37.5 mg: serious adverse events | 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.
GET https://conductscience.org/api/trials/v1/NCT01391962
GET https://conductscience.org/api/trials/v1/NCT01391962/results?page=2