NCT00942877

Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

Completed Phase 2 Results posted Last updated 3 March 2025

What this trial tests

Phase 2 trial testing AZD2171 in Sarcoma, Alveolar Soft Part in 53 participants. Completed in 31 December 2024.

Timeline

18 July 2009

Primary endpoint
30 September 2018

31 December 2024

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	18 July 2009
Primary completion	30 September 2018
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• AZD2171 — full drug profile →

Conditions studied

• Sarcoma, Alveolar Soft Part — all drugs for Sarcoma, Alveolar Soft Part →

Sponsor

National Cancer Institute (NCI)

Who can join

Under 16, any sex, with Sarcoma, Alveolar Soft Part. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) Primary · 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)

Group	Value	95% CI
Pediatric Participants w/Alveolar Soft Part Sarcoma	0

Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) Primary · 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.

Complete Response

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	0

Partial Response

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	13

Number of Participants With a Best Observed Response Primary · 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.

Complete Response

Group	Value	95% CI
Pediatric Participants w/Alveolar Soft Part Sarcoma	0

Partial Response

Group	Value	95% CI
Pediatric Participants w/Alveolar Soft Part Sarcoma	0

Stable Disease

Group	Value	95% CI
Pediatric Participants w/Alveolar Soft Part Sarcoma	5

Progressive Disease

Group	Value	95% CI
Pediatric Participants w/Alveolar Soft Part Sarcoma	2

Number of Participants With a Best Response Primary · 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.

Complete Response

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	0

Partial Response

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	13

Stable Disease

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	30

Progressive Disease

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	2

Number of Participants With Serious and Non-serious Adverse Events Secondary · 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 o

Group	Value	95% CI
Adult Participants w/Alveolar Soft Part Sarcoma	45
Pediatric Participants w/Alveolar Soft Part Sarcoma	7

Adverse events — posted to ClinicalTrials.gov

Time frame: 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). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adult Participants w/Alveolar Soft Part Sarcoma

Serious: 22/46 (48%)

Deaths: 2/46

Pediatric Participants w/Alveolar Soft Part Sarcoma

Serious: 6/7 (86%)

Deaths: 0/7

Serious adverse events (48 terms)

Reaction	System	Adult Participants w/Alveo…	Pediatric Participants w/A…
Proteinuria	Renal and urinary disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood bilirubin increased	Investigations	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Hypertension	Vascular disorders	—	—
Neutrophil count decreased	Investigations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Alkaline phosphatase increased	Investigations	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—
Bronchopulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	—	—
CPK increased	Investigations	—	—
Confusion	Psychiatric disorders	—	—
Creatinine increased	Investigations	—	—
Diarrhea	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Fever	Gastrointestinal disorders	—	—
Fracture	Injury, poisoning and procedural complications	—	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Hepatitis viral	Infections and infestations	—	—

Other adverse events (202 terms — click to expand)

Reaction	System	Adult Participants w/Alveo…	Pediatric Participants w/A…
Diarrhea	Gastrointestinal disorders	—	—
Hypertension	Vascular disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Proteinuria	Renal and urinary disorders	—	—
Fatigue	General disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Mucositis oral	Gastrointestinal disorders	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	—	—
Weight loss	Investigations	—	—
Vomiting	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—
White blood cell decreased	Investigations	—	—
Lymphocyte count decreased	Investigations	—	—
Hemoglobinuria	Renal and urinary disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Alkaline phosphatase increased	Investigations	—	—
Dizziness	Nervous system disorders	—	—
Platelet count decreased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Blood bilirubin increased	Investigations	—	—
Constipation	Gastrointestinal disorders	—	—
Hypermagnesemia	Metabolism and nutrition disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Neutrophil count decreased	Investigations	—	—
Rash acneiform	Skin and subcutaneous tissue disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Voice alteration	Respiratory, thoracic and mediastinal disorders	—	—
CPK increased	Investigations	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Proteinuria, Alanine aminotransferase increased, Dehydration, Tumor pain, Aspartate aminotransferase increased, Blood bilirubin increased, Dyspnea, Hypertension.

Data from ClinicalTrials.gov NCT00942877 adverse events section.

Sponsor's own description

Background:

* Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma.
* The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma.

Objectives:

\- To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.

Eligibility:

\- Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma.

Design:

* After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles.
* Patients will keep a study diary to record the doses taken, any missed doses, and any side effects.
* Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks during cycles 1 and 2, then at the start of each subsequent cycle, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the treatment, and possible tumor biopsy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cediranib for metastatic alveolar soft part sarcoma.
   Kummar S, Allen D, Monks A, Polley EC, et al · · 2013 · cited 155× · PMID 23630200 · DOI 10.1200/jco.2012.47.4288
2. Pediatric sarcomas: translating molecular pathogenesis of disease to novel therapeutic possibilities.
   Anderson JL, Denny CT, Tap WD, Federman N. · · 2012 · cited 42× · PMID 22546864 · DOI 10.1038/pr.2012.54
3. The landscape of tyrosine kinase inhibitors in sarcomas: looking beyond pazopanib.
   Wilding CP, Elms ML, Judson I, Tan AC, et al · · 2019 · cited 32× · PMID 31665941 · DOI 10.1080/14737140.2019.1686979
4. Alveolar soft part sarcomas: molecular pathogenesis and implications for novel targeted therapies.
   Mitton B, Federman N. · · 2012 · cited 28× · PMID 22566752 · DOI 10.1155/2012/428789
5. The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
   Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
6. Advances in treatment of alveolar soft part sarcoma: an updated review.
   Fujiwara T, Kunisada T, Nakata E, Nishida K, et al · · 2023 · cited 22× · PMID 37626447 · DOI 10.1093/jjco/hyad102
7. Dual Drug Repurposing: The Example of Saracatinib.
   Ramos R, Vale N. · · 2024 · cited 17× · PMID 38674150 · DOI 10.3390/ijms25084565
8. A randomized, double-blind phase II study evaluating cediranib versus cediranib and saracatinib in patients with relapsed metastatic clear-cell renal cancer (COSAK).
   Powles T, Brown J, Larkin J, Jones R, et al · · 2016 · cited 16× · PMID 26802156 · DOI 10.1093/annonc/mdw014