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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

No Placebo-Only Group

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Number of Participants With Serious and Non-serious Adverse Events

Side effects data

From 2011 Phase 2 trial • 119 Patients • NCT00264004

82%

Diarrhoea

75%

Hypertension

68%

Fatigue

57%

Nausea

57%

Dysphonia

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%

Anaemia

14%

Hypothyroidism

14%

Pyrexia

14%

Back Pain

14%

Proteinuria

14%

Dyspnoea

14%

Dry Skin

11%

Dry Mouth

11%

Oedema Peripheral

11%

Urinary Tract Infection

11%

Dizziness

11%

Depression

11%

Dyspnoea Exertional

11%

Epistaxis

11%

Nail Disorder

Face Oedema

Abdominal Pain

Ear Discomfort

Dysphagia

Abdominal Pain Upper

Haemorrhoids

Chest Discomfort

Temperature Intolerance

Blood Thyroid Stimulating Hormone Increased

Alanine Aminotransferase Increased

Myalgia

Neck Pain

Cancer Pain

Peripheral Sensory Neuropathy

Lethargy

Pollakiuria

Hyperhidrosis

Hypotension

Vision Blurred

Blood Bilirubin Increased

Vertigo

Cholestasis

Non-Cardiac Chest Pain

Lung Infection

Joint Swelling

Hypercalcaemia

Confusional State

Renal Impairment

Urethral Pain

Pleural Effusion

Venous Thrombosis Limb

Thrombocytopenia

Ascites

Asthenia

Mucosal Inflammation

Cystitis

Oral Candidiasis

Aspartate Aminotransferase Increased

Transaminases Increased

Decreased Appetite

Muscle Spasms

Muscular Weakness

Dysgeusia

Pharyngolaryngeal Pain

Rash

Pruritus

Pigmentation Disorder

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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