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Tyrosine Kinase Inhibitor

Cediranib for Sarcoma

Q: What security measures have been adopted to safeguard patients from potential risks of AZD2171?

Evaluators from Power have assigned AZD2171 a rank of 2, as the Phase 2 trial has provided evidence for its safety but not yet for efficacy.

Q: Is this a pioneering exploration into the therapeutic use of this drug?

AZD2171 has been the subject of rigorous medical study since 2008, when AstraZeneca sponsored its first trial with 64 participants. Following successful Phase 1 clinical trials this medication was approved for use and today there are 19 studies involving AZD2171 spanning 13 countries and 666 cities.

Q: Has AZD2171 been tested in any other clinical trials?

Currently, 19 different clinical trials are exploring the potential of AZD2171 with 3 trials reaching Phase 3. While many experiments are occurring in Akron, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a> alone, there is a remarkable global presence with 2384 sites actively administering this medication.

Q: Is this research endeavor currently seeking participants?

This experiment is documented on clinicaltrials.gov as no longer recruiting participants, a status it has held since an update to the post made in March of 2022. Initially posted in July 2009, this inactive trial is one of 463 others that are currently seeking patients for studies.

Q: How many participants may partake in this medical research project?

The recruitment period for this trial has expired; it was initially posted on July 18th 2009 and last modified on March 11th 2022. However, there are currently 444 studies recruiting patients with <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a>, alveolar soft part and 19 trials searching specifically for participants that can be treated with AZD2171.

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)

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

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 more

Secondary outcome measures

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%

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

Myalgia

Hypotension

Chest Discomfort

Face Oedema

Blood Thyroid Stimulating Hormone Increased

Hyperhidrosis

Abdominal Pain

Ear Discomfort

Dysphagia

Abdominal Pain Upper

Temperature Intolerance

Alanine Aminotransferase Increased

Neck Pain

Cancer Pain

Lethargy

Pollakiuria

Haemorrhoids

Peripheral Sensory Neuropathy

Vision Blurred

Blood Bilirubin Increased

Muscle Spasms

Asthenia

Mucosal Inflammation

Pruritus

Cholestasis

Hypercalcaemia

Confusional State

Aspartate Aminotransferase Increased

Vertigo

Renal Impairment

Urethral Pain

Pleural Effusion

Venous Thrombosis Limb

Thrombocytopenia

Ascites

Oral Candidiasis

Transaminases Increased

Decreased Appetite

Muscular Weakness

Pharyngolaryngeal Pain

Lung Infection

Joint Swelling

Non-Cardiac Chest Pain

Dysgeusia

Cystitis

Rash

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,828 Total Patients Enrolled

Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

16 Previous Clinical Trials

3,615 Total Patients Enrolled

Media Library

Cediranib (AZD2171) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00942877 — Phase 2

Alveolar Soft Part Sarcoma Research Study Groups: Cediranib (AZD2171) Treatment

Alveolar Soft Part Sarcoma Clinical Trial 2023: Cediranib (AZD2171) Highlights & Side Effects. Trial Name: NCT00942877 — Phase 2

Cediranib (AZD2171) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00942877 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What security measures have been adopted to safeguard patients from potential risks of AZD2171?

"Evaluators from Power have assigned AZD2171 a rank of 2, as the Phase 2 trial has provided evidence for its safety but not yet for efficacy."

Answered by AI

Is this a pioneering exploration into the therapeutic use of this drug?

"AZD2171 has been the subject of rigorous medical study since 2008, when AstraZeneca sponsored its first trial with 64 participants. Following successful Phase 1 clinical trials this medication was approved for use and today there are 19 studies involving AZD2171 spanning 13 countries and 666 cities."

Answered by AI

Has AZD2171 been tested in any other clinical trials?

"Currently, 19 different clinical trials are exploring the potential of AZD2171 with 3 trials reaching Phase 3. While many experiments are occurring in Akron, Ohio alone, there is a remarkable global presence with 2384 sites actively administering this medication."

Answered by AI

Is this research endeavor currently seeking participants?

"This experiment is documented on clinicaltrials.gov as no longer recruiting participants, a status it has held since an update to the post made in March of 2022. Initially posted in July 2009, this inactive trial is one of 463 others that are currently seeking patients for studies."

Answered by AI

How many participants may partake in this medical research project?

"The recruitment period for this trial has expired; it was initially posted on July 18th 2009 and last modified on March 11th 2022. However, there are currently 444 studies recruiting patients with sarcoma, alveolar soft part and 19 trials searching specifically for participants that can be treated with AZD2171."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Cediranib for Metastatic Alveolar Soft Part Sarcoma

Kummar, Shivaani, Deborah Allen, Anne Monks, Eric C. Polley, Curtis D. Hose, S. Percy Ivy, Ismail B. Turkbey, et al.. 2013. “Cediranib for Metastatic Alveolar Soft Part Sarcoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2012.47.4288.

European Urology FocusJournal

Radiological Response Heterogeneity Is of Prognostic Significance in Metastatic Renal Cell Carcinoma Treated with Vascular Endothelial Growth Factor-targeted Therapy

Hall, Peter E., Scott T.C. Shepherd, Janet Brown, James Larkin, Robert Jones, Christy Ralph, Robert Hawkins, et al.. 2020. “Radiological Response Heterogeneity Is of Prognostic Significance in Metastatic Renal Cell Carcinoma Treated with Vascular Endothelial Growth Factor-targeted Therapy”. European Urology Focus. Elsevier BV. doi:10.1016/j.euf.2019.01.010.

Pediatric Blood & CancerJournal

Cediranib Phase‐ii Study in Children with Metastatic Alveolar Soft‐part Sarcoma (ASPS)

Cohen, Julia W., Brigitte C. Widemann, Joanne Derdak, Eva Dombi, Anne Goodwin, Jessica Dompierre, Uzoma Onukwubiri, et al.. 2019. “Cediranib Phase‐ii Study in Children with Metastatic Alveolar Soft‐part Sarcoma (ASPS)”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.27987.

Annals of OncologyJournal