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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman who can have children and I have a negative pregnancy test.
Select...
My cancer is a type called alveolar soft part sarcoma and cannot be removed by surgery.
Select...
I can take care of myself and perform daily activities.
Select...
My organs and bone marrow are functioning normally.
Select...
My cancer has spread and cannot be removed by surgery.
Select...
I am 16 years old or older.
Select...
My heart pumps blood well according to my hospital's standards.
Select...
I can swallow whole tablets and capsules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the ORR of cediranib in patients who progress on thesunitinib arm, and determine the ORR of sunitinib in patients who progress on the cediranib arm
Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS
Secondary outcome measures
Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS
Perform pharmacokinetic analysis for cediranib
Side effects data
From 2015 Phase 2 & 3 trial • 1814 Patients • NCT0038417677%
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%
Cough
12%
Proteinuria
11%
Abdominal Pain Upper
11%
Nasopharyngitis
10%
Leukopenia
10%
Back Pain
9%
Alopecia
8%
Pain In Extremity
8%
Dizziness
8%
Hypokalaemia
8%
Anaemia
8%
Insomnia
8%
Urinary Tract Infection
8%
Arthralgia
7%
Oropharyngeal Pain
7%
Rash
7%
Oedema Peripheral
6%
Depression
6%
Lethargy
6%
Alanine Aminotransferase Increased
6%
Myalgia
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%
Gastrointestinal Pain
1%
Left Ventricular Dysfunction
1%
Abdominal Abscess
1%
Vena Cava Thrombosis
1%
Cerebral Haemorrhage
1%
Pleural Effusion
1%
Non-Cardiac Chest Pain
1%
Pharyngeal Oedema
1%
Pneumonia
1%
Catheter Related Infection
1%
Agranulocytosis
1%
Oesophagitis
1%
Angina Pectoris
1%
Intestinal Perforation
1%
Atrial Flutter
1%
Supraventricular Tachycardia
1%
Ileus
1%
Rectal Haemorrhage
1%
Hypercalcaemia
1%
General Physical Health Deterioration
1%
Embolism Venous
1%
Lobar Pneumonia
1%
Abdominal Infection
1%
Sepsis
1%
Transient Ischaemic Attack
1%
Haematuria
1%
Cerebrovascular Accident
1%
Cognitive Disorder
1%
Renal Failure
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part IIExperimental Treatment2 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 IExperimental Treatment2 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
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
13,657 Previous Clinical Trials
40,933,633 Total Patients Enrolled
Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
16 Previous Clinical Trials
3,634 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thyroid condition cannot be controlled with medication.I haven't had serious wounds, ulcers, or abdominal issues in the last 28 days.I have not had a stroke or mini-stroke in the last year.I do not have any uncontrolled illnesses.I can swallow and absorb medication without issues.I am a woman who can have children and I have a negative pregnancy test.I agree to use two reliable birth control methods if I can have children.I am not HIV-positive or not on antiretroviral therapy.My cancer is a type called alveolar soft part sarcoma and cannot be removed by surgery.My scans show my cancer has grown in the last 6 months.My ASPS is advanced, cannot be surgically removed, and is getting worse.I can take care of myself and perform daily activities.My organs and bone marrow are functioning normally.My cancer has spread and cannot be removed by surgery.I am 16 years old or older.My heart pumps blood well according to my hospital's standards.I can swallow whole tablets and capsules.I have not had heart or artery surgery or stenting in the last year.I have never been treated with VEGF receptor inhibitors.I have not had major surgery in the last 4 weeks.I have a family history of long QT syndrome or take medications that may extend QTc.I finished my last cancer treatment more than 4 weeks ago.I am not taking Warfarin or similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: Part II
- Group 2: Part I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what ailments is Cediranib commonly prescribed?
"Cediranib has been approved to treat multiple conditions, namely soft tissue sarcoma (sts), gastrointestinal stromal tumors, metastatic pancreatic neuroendocrine tumours, and advanced renal cell carcinoma (arcc)."
Answered by AI
Have there been any other investigations into the efficacy of Cediranib?
"Currently, 52 clinical trials are underway researching cediranib. 14 of these active experiments have advanced to Phase 3 and 6241 sites across the globe are running studies related to this treatment - with a great number located in Emmett, Idaho."
Answered by AI
Are there currently any opportunities for participants to join this experiment?
"Unfortunately, no further participants are being sought for this clinical trial. The study was first listed on July 18th 2011 and last updated on November 19th 2022. For those looking to register with other medical trials, 444 studies involving sarcoma alveolar soft part are actively seeking patients while Cediranib has 52 open spots available."
Answered by AI
What potential side effects should be taken into account when considering the utilization of Cediranib?
"Our team at Power has given Cediranib a rating of 2, as clinical trials have provided evidence that it is safe, yet efficacy remains unproven."
Answered by AI
How many participants have been enrolled for this trial at its maximum capacity?
"Unfortunately, recruitment for this trial has concluded. It was first listed on July 18th 2011 and edited lastly on November 19th 2022. As an alternative, currently 444 clinical trials are actively seeking patients with sarcoma or alveolar soft part while 52 studies require people to enrol in Cediranib research."
Answered by AI
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