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Sarcoma, Alveolar Soft PartPhase 2NCT01391962

Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

A Phase 2 study testing Cediranib, Sunitinib and Prochlorperazine in people with Sarcoma, Alveolar Soft Part, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets. Read more about this study

Who is it for?
Ages 16 to 120 years
Conditions the study is for
Sarcoma, Alveolar Soft Part
What is being tested?
Cediranib, Sunitinib and Prochlorperazine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
18 Jul 2011to 16 Jan 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Status Update: Patients enrolled after Amendment G (version dated 08/16/2013), will be evaluated and compared to the first 13 patients by the study statistician and the Principal Investigator.
  • Patients must have histologically confirmed metastatic alveolar soft part sarcoma that is not curable by surgery. Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment.
  • Patients must show evidence of objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST)v 1 on scans within the 6-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period.
  • Patients with newly diagnosed, unresectable, metastatic, and measurable alveolar soft part sarcoma (ASPS) who show clinical evidence of disease progression (including history and increasing physical symptoms) will also be eligible. On-study documentation will include a physician's rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain).
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral computed tomography (CT) scan.
  • Any prior therapy must have been completed greater than or equal to 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity. Patients should be at least 6 weeks out from nitrosoureas and mitomycin C. Prior radiation should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels. Patients who have had prior monoclonal antibody therapy must have completed that therapy at least 3 half-lives of the antibody or 6 weeks ago. Patients who have received more than a cumulative dose of 350 mg/m(2) of doxorubicin may be enrolled at the discretion of the Coordinating Center PI after consultation with a cardiologist and if screening echocardiogram is normal.
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  • Patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a Phase 0 study (also referred to as an early Phase I study or pre-Phase I study where a sub-therapeutic dose of drug is administered) at the Coordinating Center principal investigator (PI's) discretion and should have recovered to eligibility levels from any toxicities.
  • Patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery.
  • Age greater than or equal to 16 years. Patients age 16-17 years are eligible only if they have a BSA greater than or equal to 1.7 m(2) or weigh greater than or equal to 60 kg.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
  • Life expectancy of greater than 3 months.
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes greater than or equal to 3,000/mcL
  • absolute neutrophil count greater than or equal to 1,500/mcL
  • platelets greater than or equal to 100,000/mcL
  • hemoglobin greater than or equal to 9 g/dL
  • total serum bilirubin within normal institutional limits
  • aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase (SGPT) less than or equal to 2.5 times institutional upper limit of normal
  • creatinine within normal institutional limits
  • OR
  • creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels above institutional normal
  • QT corrected for heart rate (QTc) <480 msec (with Bazett's correction) in screening electrocardiogram.
  • The following groups of patients are eligible after consultation with a cardiologist and at the Coordinating Center PI's discretion, provided they have New York Heart Association Class II (NYHA) cardiac function on baseline echocardiogram (ECHO):
  • those with a history of Class II heart failure who are asymptomatic on treatment
  • those with prior anthracycline exposure greater than a cumulative dose of 350 mg/m(2)
  • those who have received central thoracic radiation that included the heart in the radiotherapy port.
  • Patients must have blood pressure (BP) no greater than 140 millimeters of mercury (mmHg) (systolic) and 90 mmHg (diastolic) for eligibility. Initiation or adjustment of BP medication is permitted prior to study entry provided that the BP reading prior to enrollment is no greater than 140/90 mmHg.
  • Left ventricular ejection fraction (LVEF) greater than or equal to institutional lower limit of normal.
  • Because sunitinib is metabolized primarily by the cytochrome P450 3A4 (CYP3A4) liver enzyme, strong CYP3A4 inhibitors are not permitted within 7 days before and during the study, and strong CYP3A4 inducers are not permitted within 12 days before and during the study. A list of drugs that may interact with the cytochrome P450 system is included in Appendix C. Every effort should be made to switch patients taking such agents or substances to other medications 1 week prior to starting therapy, particularly patients with brain metastases who are taking enzyme- inducing anticonvulsant agents (Appendix D). Patients who require potent CYP3A4 inducers or inhibitors and cannot switch medications must have their case reviewed by the Coordinating Center PI and may be enrolled only after discussion with and agreement from the Coordinating Center PI. Current clinical studies with cediranib have not found clinically significant effects on cediranib pharmacokinetic (PK) with co-administration of CYP3A4 inducers or inhibitors. Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics (PK) of cediranib will be determined following review of their case by the Coordinating Center PI.
  • Both study agents have been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling. For this reason, women of childbearing potential must have a negative pregnancy test prior to study entry.
  • Women of child-bearing potential and men must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months following study drug discontinuation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Patients who are nursing infants: because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must be able to swallow whole tablets and capsules.

Who cannot join

  • Patients must not have received prior treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed.
  • Patients may not be receiving any other investigational agents.
  • Major surgery within 4 weeks prior to entry into the study, or a surgical incision that is not fully healed.
  • History of familial long QT syndrome, or use of medications that may cause QTc interval prolongation.
  • Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible.
  • Warfarin and its derivatives are not allowed. Patient can be receiving low molecular weight heparin if clinically indicated.
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  • Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow, retain, and/or absorb the drug are excluded.
  • Patients with any of the following conditions are excluded: serious or non-healing wound, ulcer; history of abdominal fistula, gastrointestinal perforation, or intra - abdominal abscess within 28 days of treatment; coronary/peripheral artery bypass graft or stenting within the past 12 months; or cerebrovascular accident (CVA) or transient ischemic attack within the past 12 months.
  • Greater than 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart or 24-hour urine protein of > 1 g. Patients with < 2+ proteinuria are eligible following initial determination by urinalysis within 1 week prior to enrollment and do not need the urinalysis repeated.
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with cediranib or sunitinib. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase II Trial In Which Patients With Metastatic Alveolar Soft Part Sarcoma Are Randomized to Either Sunitinib or Cediranib Monotherapy, With Cross-Over at Disease Progression

Background:

  • Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets.
  • Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, are showing preliminary evidence of activity in patients with ASPS.
Read more

Objectives:

  • Part I: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.
  • Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm, and determine the ORR of sunitinib in patients who progress on the cediranib arm.
  • Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.

Eligibility:

  • Patients aged greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS.
  • Patients must show evidence of objective disease progression per Response evaluation criteria in solid tumors (RECIST)v1 on scans within the 3-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period.
  • Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show clinical evidence of disease progression will be eligible.
  • Patients must not have received treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed.

Design:

  • Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles.
  • Part II: At the time of disease progression, patients will cross over to the other treatment arm after a 2-week wash-out period.
  • Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles for restaging.
  • The study will be conducted using an optimal two-stage design to rule out an unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high response rate of 40%.

The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10 patients has a clinical response, then no further patients will be accrued. If 2 or more the first 10 patients have a response, then accrual continues to a total of 22 patients in each arm.

Read the detailed description

Background:

  • Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets.
  • Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, are showing preliminary evidence of activity in patients with ASPS.

Objectives:

  • Part I: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.
  • Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm and determine the ORR of sunitinib in patients who progress on the cediranib arm.
  • Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.

Eligibility:

Status Update: Patients enrolled after Amendment G (version dated 08/16/2013), will be evaluated and compared to the first 13 patients by the study statistician and the Principal Investigator. Patients with newly diagnosed ASPS with clinical evidence of disease progression will also be assessed separately.

  • Patients aged greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS.
  • Patients must show evidence of objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST)v 1 on scans within the 3-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period.
  • Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show clinical evidence of disease progression will be eligible.
  • Patients must not have received treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed.

Design:

  • Two sets of patients will be enrolled and assessed in separate cohorts: a) patients with non-newly diagnosed ASPS and b) patients with newly diagnosed ASPS
  • Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles. As of May 6, 2019, we have closed the cediranib arm of the newly diagnosed ASPS cohort due to inadequate activity per the statistical plan; all newly diagnosed ASPS patients will be assigned to the sunitinib malate treatment arm.
  • Part II: At the time of disease progression, patients will cross over to the other treatment arm after a 2-week wash-out period. As of May 6, 2019, patients in the newly diagnosed ASPS cohort are not eligible to cross over to the cediranib treatment arm, which was closed due to inadequate activity.
  • Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles for restaging.
  • The study will be conducted using an optimal two-stage design to rule out an unacceptably low 15% clinical response rate partial response + complete response (PR+CR) in favor of a modestly high response rate of 40%.

The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10 patients has a clinical response, then no further patients will be accrued. If 2 or more the first 10 patients have a response, then accrual continues to a total of 22 patients in each arm.

Being tested
Cediranib, Sunitinib, Prochlorperazine, Promethazine, Benzodiazepine
Keywords
Pharmacodynamics, VEGF Inhibitor, Alveolar Soft Part Sarcoma, Anti-Angiogenesis, Gene Expression Profiling
Medical subject headings
Sarcoma, Alveolar Soft Part

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CediranibDrug

    Also called AZD2171 maleate, Recentin, AXD2171

    Cediranib, a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, is showing preliminary evidence of activity in patients with alveolar soft part sarcoma (ASPS).

  • SunitinibDrug

    Also called Sutent, SU11248, SU011248

    Sunitinib, a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, is showing preliminary evidence of activity in patients with alveolar soft part sarcoma (ASPS).

  • ProchlorperazineOther

    Also called Compro

    10mg every 6 hours orally as needed for nausea,

  • PromethazineOther

    Also called Phenadoz, Phenergan, Promethegan

    12.5-25mg intravenous every 6 hours as needed for nausea.

  • BenzodiazepineOther

    Also called Valium, Diazepam, Estazolam, ProSom

    If promethazine is inadequate, add benzodiazepine until acute nausea is controlled.

  • FilgrastimOther

    Also called Neupogen

    Therapeutic use per investigator's discretion according to American Society of Clinical Oncology (ASCO) guidelines.

  • SargramostimOther

    Also called Leukine

    Therapeutic use per investigator's discretion according to American Society of Clinical Oncology (ASCO) guidelines.

  • LomotilOther

    Also called Diphenoxylate hydrochloride (HCL)/atropine

    2.5mg plus atropine sulfate 0.025mg/tablet dosed according to package insert.

  • LoperamideOther

    Also called Imodium, Diamode, Anti-Diarrheal (loperamide)

    4mg by mouth (PO) after first unformed stool with 2mg PO every 2 hours as long as unformed stools continue.

  • Vitamin B6Other

    Also called Pyridoxine

    50-150mg orally each day for hand-foot syndrome.

  • AquaphorOther

    Topical emollient for hand-foot syndrome.

  • AcetaminophenDrug

    Also called Tylenol, Ofirmev, FeverAll

    Analgesic for hand foot syndrome as needed.

  • LevothyroxineDrug

    Also called Synthroid, Tirosint, Unithroid

    Replacement therapy for participants with increases in thyroid-stimulating hormone.

  • WarfarinDrug

    Also called Coumadin

    2mg daily for prophylaxis of thrombosis.

Study groups in NCT01391962
Study groupRoleWhat they receive
Part I - Cediranib (30 mg) or Sunitinib Malate (37.5 mg) OrallyExperimentalPatients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles.
Receives: Drug: Cediranib; Drug: Sunitinib; Other: Prochlorperazine; Other: Promethazine; Other: Benzodiazepine; Other: Filgrastim; Other: Sargramostim; Other: Lomotil; Other: Loperamide; Other: Vitamin B6; Other: Aquaphor; Drug: Acetaminophen; Drug: Levothyroxine; Drug: Warfarin
Part II - Cross OverExperimentalAt the time of disease progression, patients will cross over to the other treatment arm after a 2-week wash-out period.
Receives: Drug: Cediranib; Drug: Sunitinib; Other: Prochlorperazine; Other: Promethazine; Other: Benzodiazepine; Other: Filgrastim; Other: Sargramostim; Other: Lomotil; Other: Loperamide; Other: Vitamin B6; Other: Aquaphor; Drug: Acetaminophen; Drug: Levothyroxine; Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS)

    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.

    Measured: Time on treatment (an average of 497 days or 16 months)

  2. Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS)

    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.

    Measured: Time on treatment (an average of 497 days or 16 months)

  3. Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I

    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.

    Measured: Time on treatment (an average of 497 days or 16 months)

  4. Part II: Objective Response Rate (ORR) of Cediranib in Participants Who Progress on the Sunitinib Arm During Part I

    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.

    Measured: Time on treatment (an average of 497 days or 16 months)

Secondary outcomes (3)

  1. Maximum Observed Plasma Concentration of Cediranib

    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.

    Measured: 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)

  2. 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-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.

    Measured: 24 weeks

  3. Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

    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.

    Measured: Date treatment consent signed to date off study, an average of 523 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2011 (estimated)
  2. Study start18 Jul 2011
  3. Primary completion6 Nov 2023
  4. Study completion16 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01391962
Sponsor's protocol ID
110200
Other IDs
11-C-0200
Status last verified
Jan 2026
First submitted
9 Jul 2011
Last updated
2 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Publications

  • Anderson ME, Hornicek FJ, Gebhardt MC, Raskin KA, Mankin HJ. Alveolar soft part sarcoma: a rare and enigmatic entity. Clin Orthop Relat Res. 2005 Sep;438:144-8. doi: 10.1097/01.blo.0000180049.50832.4a.

    PubMed 16131883

  • Azizi AA, Haberler C, Czech T, Gupper A, Prayer D, Breitschopf H, Acker T, Slavc I. Vascular-endothelial-growth-factor (VEGF) expression and possible response to angiogenesis inhibitor bevacizumab in metastatic alveolar soft part sarcoma. Lancet Oncol. 2006 Jun;7(6):521-3. doi: 10.1016/S1470-2045(06)70729-X. No abstract available.

    PubMed 16750504

  • Bello CL, Sherman L, Zhou J, Verkh L, Smeraglia J, Mount J, Klamerus KJ. Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects. Anticancer Drugs. 2006 Mar;17(3):353-8. doi: 10.1097/00001813-200603000-00015.

    PubMed 16520665

  • Nguyen J, Takebe N, Kummar S, Razak A, Chawla SP, George S, Patel SR, Keohan ML, Movva S, O'Sullivan Coyne G, Do K, Juwara L, Augustine B, Steinberg SM, Kuhlmann L, Ivy SP, Doroshow JH, Chen AP. Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma. Clin Cancer Res. 2023 Apr 3;29(7):1200-1208. doi: 10.1158/1078-0432.CCR-22-2145.

    PubMed 36302173

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cediranib, Sunitinib and Prochlorperazine in people with Sarcoma, Alveolar Soft Part, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) (time frame: Time on treatment (an average of 497 days or 16 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01391962, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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