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Tyrosine Kinase Inhibitor
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
Study Summary
This trial is testing whether the experimental drug AZD2171 can effectively treat alveolar soft part sarcoma by inhibiting tumor growth.
Who is the study for?
Adults diagnosed with alveolar soft part sarcoma can join this trial. They must have a tumor that's measurable on scans, be in relatively good health, and not pregnant or breastfeeding. Participants need to have normal organ function and blood pressure, and cannot be taking certain drugs that affect kidney function or interact with the study drug.Check my eligibility
What is being tested?
The trial is testing AZD2171 (cediranib), an experimental drug designed to stop tumors from growing new blood vessels. Patients will take cediranib daily in 28-day cycles, recording doses and side effects in a diary. Their response to treatment will be monitored through regular clinic visits, tests, scans, and possibly biopsies.See study design
What are the potential side effects?
Cediranib may cause high blood pressure, bleeding problems, fatigue, hand-foot syndrome (redness and pain on palms or soles), diarrhea, mouth sores, decreased appetite or weight loss. It might also lead to issues with wound healing after surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS)
Number of Participants With a Best Observed Response
Number of Participants With a Best Response
+1 moreSecondary outcome measures
Number of Participants With Serious and Non-serious Adverse Events
Side effects data
From 2011 Phase 2 trial • 119 Patients • NCT0026400482%
Diarrhoea
75%
Hypertension
68%
Fatigue
57%
Dysphonia
57%
Nausea
50%
Anorexia
36%
Stomatitis
32%
Constipation
32%
Vomiting
29%
Weight Decreased
25%
Nasopharyngitis
25%
Headache
21%
Cough
18%
Arthralgia
18%
Pain In Extremity
18%
Insomnia
18%
Palmar-Plantar Erythrodysaesthesia Syndrome
14%
Dyspnoea
14%
Back Pain
14%
Anaemia
14%
Hypothyroidism
14%
Pyrexia
14%
Proteinuria
14%
Dry Skin
11%
Epistaxis
11%
Dyspnoea Exertional
11%
Oedema Peripheral
11%
Urinary Tract Infection
11%
Dry Mouth
11%
Dizziness
11%
Depression
11%
Nail Disorder
7%
Myalgia
7%
Hypotension
7%
Chest Discomfort
7%
Face Oedema
7%
Blood Thyroid Stimulating Hormone Increased
7%
Hyperhidrosis
7%
Abdominal Pain
7%
Ear Discomfort
7%
Dysphagia
7%
Abdominal Pain Upper
7%
Temperature Intolerance
7%
Alanine Aminotransferase Increased
7%
Neck Pain
7%
Cancer Pain
7%
Lethargy
7%
Pollakiuria
7%
Haemorrhoids
7%
Peripheral Sensory Neuropathy
7%
Vision Blurred
7%
Blood Bilirubin Increased
4%
Pruritus
4%
Mucosal Inflammation
4%
Cholestasis
4%
Muscle Spasms
4%
Asthenia
4%
Hypercalcaemia
4%
Confusional State
4%
Aspartate Aminotransferase Increased
4%
Vertigo
4%
Renal Impairment
4%
Urethral Pain
4%
Pleural Effusion
4%
Venous Thrombosis Limb
4%
Thrombocytopenia
4%
Ascites
4%
Oral Candidiasis
4%
Transaminases Increased
4%
Decreased Appetite
4%
Muscular Weakness
4%
Pharyngolaryngeal Pain
4%
Lung Infection
4%
Joint Swelling
4%
Non-Cardiac Chest Pain
4%
Dysgeusia
4%
Cystitis
4%
Rash
4%
Pigmentation Disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD2171 30 mg Anti HT
AZD2171 30 mg No Anti HT
AZD2171 45 mg Anti HT
AZD2171 45 mg No Anti HT
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cediranib (AZD2171) TreatmentExperimental Treatment1 Intervention
Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).
Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2171
2008
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,261 Total Patients Enrolled
Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
3,690 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not taking any medications that can significantly affect your kidney function.It's okay if you have received treatment with medications that target blood vessel growth before.You are older than 15 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cediranib (AZD2171) Treatment
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.
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