Trial · NCT00942877
Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma
NCT00942877, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma. Trials, record NCT00942877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00942877
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma
- NCT number
- NCT00942877
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Sarcoma, Alveolar Soft Part
- Interventions
- AZD2171
- First posted
- 2009-07-21
- Last updated
- 2025-03-03
- Results first posted
- 2021-04-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) | Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. A minimal response is defined as a 5% overall response rate (Partial Response (PR) + Complete Response (CR) |
| Primary | Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) | 2 cycles (e.g., one cycle = 28 days) | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all no-target lesions 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 LD. |
| Primary | Number of Participants With a Best Observed Response | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions 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. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Primary | Number of Participants With a Best Response | Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions 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. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) | Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) | 2 cycles (e.g., one cycle = 28 days) | 45/46 participants were analyzed because one participant was not treated. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Best Observed Response | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Best Response | Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | 45/46 participants were analyzed because one participant did not receive any treatment on the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) | Pediatric Participants w/Alveolar Soft Part Sarcoma | 0 | Participants | ||
| Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) | Adult Participants w/Alveolar Soft Part Sarcoma | Complete Response | 0 | Participants | |
| Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) | Adult Participants w/Alveolar Soft Part Sarcoma | Partial Response | 13 | Participants | |
| Number of Participants With a Best Observed Response | Pediatric Participants w/Alveolar Soft Part Sarcoma | Complete Response | 0 | Participants | |
| Number of Participants With a Best Observed Response | Pediatric Participants w/Alveolar Soft Part Sarcoma | Partial Response | 0 | Participants | |
| Number of Participants With a Best Observed Response | Pediatric Participants w/Alveolar Soft Part Sarcoma | Stable Disease | 5 | Participants | |
| Number of Participants With a Best Observed Response | Pediatric Participants w/Alveolar Soft Part Sarcoma | Progressive Disease | 2 | Participants | |
| Number of Participants With a Best Response | Adult Participants w/Alveolar Soft Part Sarcoma | Complete Response | 0 | Participants | |
| Number of Participants With a Best Response | Adult Participants w/Alveolar Soft Part Sarcoma | Partial Response | 13 | Participants | |
| Number of Participants With a Best Response | Adult Participants w/Alveolar Soft Part Sarcoma | Stable Disease | 30 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adult Participants w/Alveolar Soft Part Sarcoma | 46 | |
| Overall Study | STARTED | Pediatric Participants w/Alveolar Soft Part Sarcoma | 7 | |
| Overall Study | COMPLETED | Adult Participants w/Alveolar Soft Part Sarcoma | 1 | |
| Overall Study | COMPLETED | Pediatric Participants w/Alveolar Soft Part Sarcoma | 3 | |
| Overall Study | NOT COMPLETED | Adult Participants w/Alveolar Soft Part Sarcoma | 45 | |
| Overall Study | NOT COMPLETED | Pediatric Participants w/Alveolar Soft Part Sarcoma | 4 |
Source ClinicalTrials.gov
Adverse events500
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 distension | Gastrointestinal disorders | Adult Participants w/Alveolar Soft Part Sarcoma | 3 | 46 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Pediatric Participants w/Alveolar Soft Part Sarcoma | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Adult Participants w/Alveolar Soft Part Sarcoma | 30 | 46 | 66 |
| other | Abdominal pain | Gastrointestinal disorders | Pediatric Participants w/Alveolar Soft Part Sarcoma | 4 | 7 | 7 |
| other | Activated partial thromboplastin time prolonged | Investigations | Adult Participants w/Alveolar Soft Part Sarcoma | 2 | 46 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Pediatric Participants w/Alveolar Soft Part Sarcoma | 1 | 7 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Adult Participants w/Alveolar Soft Part Sarcoma | 1 | 46 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Pediatric Participants w/Alveolar Soft Part Sarcoma | 0 | 7 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Adult Participants w/Alveolar Soft Part Sarcoma | 1 | 46 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Pediatric Participants w/Alveolar Soft Part Sarcoma | 0 | 7 | 0 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adult Participants w/Alveolar Soft Part Sarcoma | 2 | 46 |
| Total, all-cause mortality | Pediatric Participants w/Alveolar Soft Part Sarcoma | 0 | 7 |
| Total, other adverse events | Adult Participants w/Alveolar Soft Part Sarcoma | 45 | 46 |
| Total, other adverse events | Pediatric Participants w/Alveolar Soft Part Sarcoma | 7 | 7 |
| Total, serious adverse events | Adult Participants w/Alveolar Soft Part Sarcoma | 22 | 46 |
| Total, serious adverse events | Pediatric Participants w/Alveolar Soft Part Sarcoma | 6 | 7 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adult Participants w/Alveolar Soft Part Sarcoma vs Pediatric Participants w/Alveolar Soft Part Sarcoma: Number of Participants With Serious and Non-serious Adverse Events | Trial comparisons |
| Adult Participants w/Alveolar Soft Part Sarcoma vs Pediatric Participants w/Alveolar Soft Part Sarcoma: deaths from any cause | Trial comparisons |
| Adult Participants w/Alveolar Soft Part Sarcoma vs Pediatric Participants w/Alveolar Soft Part Sarcoma: 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/NCT00942877
GET https://conductscience.org/api/trials/v1/NCT00942877/events?page=2