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AZD2171

Phase 2

Advanced Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 3, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

AZD2171 · 16 trials · 21 indications

Phase 2 4Phase 1 12
NCT00454805AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.Advanced Breast Cancer
COMPLETED75 Analytics
NCT00385203The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).Gastrointestinal Stromal Tumors
COMPLETED35 Analytics
NCT00278889Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)Colorectal Cancer
COMPLETED215 Analytics
NCT00264004Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid TumoursTumors
COMPLETED119 Analytics
PHASE2COMPLETED
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
Advanced Breast CancerUnlock trial analytics
PHASE2COMPLETED
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
Gastrointestinal Stromal TumorsUnlock trial analytics
PHASE2COMPLETED
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
Colorectal CancerUnlock trial analytics
PHASE2COMPLETED
Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours
TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival
RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.
Baseline and 8 days after dosing.

\[F 18\] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.

Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.
FDG-PET assessment at Baseline and 29 days after dosing.

SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
12 week treatment period
Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171
12 week treatment period

Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).
From date of consent through to data cut-off, 7th August 2009.
To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).
Single dose PK assessed on Day 1 of dosing
Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam
assessed at each visit
Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
Randomisation until Day 22

Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100

The primary objective is to determine the rates & routes of excretion of 14C radiolabelled AZD2171 in patients by assessment of concentrations of total 14C radioactivity and AZD2171 in plasma & concentrations of total radioactivity in urine&faeces
assessed at time intervals post dose
Safety and tolerability
Assessed at each visit for 4 weeks
Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel
After 5 weeks of treatment
primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839
The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam.

Secondary Endpoints

Objective Response Rate
RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Duration of Response
Every 8 weeks until progression or discontinuation
Clinical Benefit Rate
Every 8 weeks until progression or discontinuation
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2ACTIVE_COMPARATORFulvestrant Monotherapy
3EXPERIMENTALAZD2171 + Fulvestrant
1ACTIVE_COMPARATORBevacizumab + FOLFOX
FOLFOX + Cediranib 20 mgACTIVE_COMPARATORFOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 30 mgACTIVE_COMPARATORFOLFOX + Cediranib 30 mg
FOLFOX + Placebo CediranibPLACEBO_COMPARATORFOLFOX + Placebo Cediranib

Interventions

NameTypeDescription
AZD2171DRUGOral tablet
FulvestrantDRUGintramuscular injection
5-fluorouracilDRUGintravenous infusion
LeucovorinDRUGintravenous infusion
OxaliplatinDRUGintravenous infusion
BevacizumabDRUGintravenous infusion
EtoposideDRUGIntravenous
CisplatinDRUGIntravenous
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)DRUGintravenous infusion
Placebo CediranibDRUGoral tablet
AZD0530DRUGoral tablet multiple ascending doses 125 mg or 175 mg
FOLFOXDRUGintravenous infusion
PemetrexedDRUGintravenous infusion
Irinotecan (administered with & without Cetuximab)DRUGintravenous injection
DocetaxelDRUGintravenous infusion
ZD1839DRUG -
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Eligibility Criteria

Age Range18 Years to 130 Years
SexFEMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Written informed consent * Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease * One or more evaluable lesions Exclusion Criteria: * Prior hormonal therapy with fulvestrant * More than one course of prior ...

Countries:United StatesAustraliaBrazilUnited KingdomAustriaBelgiumCanadaCzechiaFranceGermanyItalySpainNetherlandsDenmarkJapan
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Competitive Landscape -Breast Cancer 402 trials (matched to "Advanced Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about AZD2171

What is AZD2171 used for?

AZD2171 is an investigational small molecule being studied in oncology. It has been evaluated in clinical trials for metastatic colorectal cancer, advanced breast cancer, non-small cell lung cancer, head and neck cancer, and advanced solid tumors. It is not approved and remains in clinical development.

What does AZD2171 target?

AZD2171 is a small molecule that targets vascular endothelial growth factor receptors (VEGFR), inhibiting tumor angiogenesis. It is being studied to determine its effects in various advanced cancers, including colorectal cancer and breast cancer.

Who makes AZD2171?

AZD2171 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in Phase 2 clinical development for oncology indications.

What phase is AZD2171 in?

AZD2171 is in Phase 2 clinical development. It has completed three trials, including Phase 1 and Phase 2 studies, with a total enrollment of 224 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD2171 in?

AZD2171 has completed three clinical trials: NCT00243347 in non-small cell lung cancer and head and neck cancer, NCT00278889 in colorectal cancer, and NCT00454805 in advanced breast cancer. All trials are completed, with no active trials ongoing.

Is AZD2171 the same as cediranib?

Yes, AZD2171 is also known as cediranib. A completed Phase 1 study, NCT00621725, evaluated cediranib in patients with solid tumors and hepatic impairment. The drug is being developed by AstraZeneca for multiple oncology indications.