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Tyrosine Kinase Inhibitor

Sunitinib vs Cediranib for Sarcoma

Phase 2
Waitlist Available
Led By Alice P Chen, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential must have a negative pregnancy test prior to study entry
Patients must have histologically confirmed metastatic alveolar soft part sarcoma that is not curable by surgery
Must not have
Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication
Serious or non-healing wound, ulcer; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effects of two drugs, cediranib and sunitinib, on patients with a rare cancer called alveolar soft part sarcoma. The trial will see if either of the drugs help to shrink the tumors, and if so, which drug works better.

Who is the study for?
This trial is for people aged 16 or older with a specific type of cancer called metastatic Alveolar Soft Part Sarcoma (ASPS). They should have measurable disease progression and normal organ/marrow function. Those who've had certain treatments like VEGF receptor tyrosine kinase inhibitors can't join, but prior bevacizumab treatment is okay.
What is being tested?
The trial tests two oral drugs, Cediranib and Sunitinib, which inhibit blood vessel growth in tumors. Participants will randomly receive one drug first and then switch to the other if their cancer progresses. The main goals are to see how well these drugs shrink the tumors and how long patients stay free from disease worsening.
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, diarrhea, hand-foot syndrome (redness/pain/swelling of hands/feet), mouth sores, low white blood cell counts increasing infection risk, bleeding issues due to low platelets count, and possibly heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and I have a negative pregnancy test.
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My cancer is a type called alveolar soft part sarcoma and cannot be removed by surgery.
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I can take care of myself and perform daily activities.
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My organs and bone marrow are functioning normally.
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My cancer has spread and cannot be removed by surgery.
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I am 16 years old or older.
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My heart pumps blood well according to my hospital's standards.
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I can swallow whole tablets and capsules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My thyroid condition cannot be controlled with medication.
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I haven't had serious wounds, ulcers, or abdominal issues in the last 28 days.
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I do not have any uncontrolled illnesses.
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I can swallow and absorb medication without issues.
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I am not HIV-positive or not on antiretroviral therapy.
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I have not had heart or artery surgery or stenting in the last year.
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I have never been treated with VEGF receptor inhibitors.
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I have a family history of long QT syndrome or take medications that may extend QTc.
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I am not taking Warfarin or similar medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS)
Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS)
Part II: Objective Response Rate (ORR) of Cediranib in Participants Who Progress on the Sunitinib Arm During Part I
+1 more
Secondary study objectives
Maximum Observed Plasma Concentration of Cediranib
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
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
Other study objectives
Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed
Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed
Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks During Part I for Participants Who Were Not Newly Diagnosed
+1 more

Side effects data

From 2015 Phase 2 & 3 trial • 1814 Patients • NCT00384176
77%
Diarrhoea
52%
Nausea
48%
Hypertension
47%
Fatigue
45%
Neutropenia
40%
Stomatitis
37%
Decreased Appetite
34%
Vomiting
29%
Thrombocytopenia
26%
Neuropathy Peripheral
26%
Abdominal Pain
25%
Dysphonia
24%
Headache
24%
Epistaxis
24%
Paraesthesia
19%
Peripheral Sensory Neuropathy
18%
Constipation
17%
Weight Decreased
16%
Palmar-Plantar Erythrodysaesthesia Syndrome
16%
Asthenia
14%
Dyspnoea
14%
Pyrexia
13%
Dysgeusia
13%
Hypothyroidism
12%
Proteinuria
12%
Cough
11%
Abdominal Pain Upper
11%
Nasopharyngitis
10%
Leukopenia
10%
Back Pain
9%
Alopecia
8%
Hypokalaemia
8%
Urinary Tract Infection
8%
Dizziness
8%
Anaemia
8%
Pain In Extremity
8%
Insomnia
8%
Arthralgia
7%
Rash
7%
Oropharyngeal Pain
7%
Oedema Peripheral
6%
Lethargy
6%
Myalgia
6%
Alanine Aminotransferase Increased
6%
Depression
6%
Dysphagia
6%
Dyspepsia
5%
Drug Hypersensitivity
5%
Dry Mouth
5%
Phlebitis
4%
Musculoskeletal Pain
3%
Dehydration
3%
Pulmonary Embolism
2%
Upper Respiratory Tract Infection
1%
Pleural Effusion
1%
Hypercalcaemia
1%
Transient Ischaemic Attack
1%
Embolism Venous
1%
Abdominal Abscess
1%
Supraventricular Tachycardia
1%
Gastrointestinal Pain
1%
Sepsis
1%
Haematuria
1%
Ileus
1%
General Physical Health Deterioration
1%
Vena Cava Thrombosis
1%
Left Ventricular Dysfunction
1%
Oesophagitis
1%
Pneumonia
1%
Pharyngeal Oedema
1%
Rectal Haemorrhage
1%
Non-Cardiac Chest Pain
1%
Catheter Related Infection
1%
Abdominal Infection
1%
Lobar Pneumonia
1%
Renal Failure
1%
Cerebral Haemorrhage
1%
Angina Pectoris
1%
Atrial Flutter
1%
Cerebrovascular Accident
1%
Cognitive Disorder
1%
Agranulocytosis
1%
Intestinal Perforation
1%
Convulsion
1%
Deep Vein Thrombosis
1%
Cardiomyopathy
1%
Enteritis
1%
Gastrointestinal Toxicity
1%
Ileus Paralytic
1%
Large Intestinal Obstruction
1%
Appendicitis
1%
Bronchitis
1%
Catheter Site Cellulitis
1%
Neutropenic Sepsis
1%
Pulmonary Tuberculosis
1%
Syncope
1%
Cerebral Ischaemia
1%
Haemorrhagic Stroke
1%
Vascular Encephalopathy
1%
Subclavian Vein Thrombosis
1%
Thrombosis
1%
Cardiopulmonary Failure
1%
Mitral Valve Incompetence
1%
Myocardial Ischaemia
1%
Intestinal Haemorrhage
1%
Bradyphrenia
1%
Hypertensive Crisis
1%
Febrile Neutropenia
1%
Pancytopenia
1%
Intestinal Obstruction
1%
Gastrointestinal Inflammation
1%
Large Intestine Perforation
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cediranib 30 mg
1Bevacizumab 5mg/kg
Cediranib 20 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part II - Cross OverExperimental Treatment14 Interventions
At the time of disease progression, patients will cross over to the other treatment arm after a 2-week wash-out period.
Group II: Part I - Cediranib (30 mg) or Sunitinib Malate (37.5 mg) OrallyExperimental Treatment14 Interventions
Patients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Warfarin
2017
Completed Phase 4
~248220
Levothyroxine
2013
Completed Phase 4
~3840
Sunitinib
2014
Completed Phase 3
~4380
Cediranib
2016
Completed Phase 3
~4030

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,203 Total Patients Enrolled
Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
3,797 Total Patients Enrolled

Media Library

Cediranib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01391962 — Phase 2
Alveolar Soft Part Sarcoma Research Study Groups: Part I - Cediranib (30 mg) or Sunitinib Malate (37.5 mg) Orally, Part II - Cross Over
Alveolar Soft Part Sarcoma Clinical Trial 2023: Cediranib Highlights & Side Effects. Trial Name: NCT01391962 — Phase 2
Cediranib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01391962 — Phase 2
~2 spots leftby Dec 2025
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