Recent Updates
Recently added Catalysts

AZD0530

Phase 2

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 27, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

AZD0530 · 6 trials · 8 indications

Phase 2 2Phase 1 4
NCT00610714AZD0530 Phase II Study in Patients With Advanced Ovarian CancerOvarian Neoplasms
COMPLETED211 Analytics
NCT00558272Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone DiseaseBreast Cancer
COMPLETED139 Analytics
PHASE2COMPLETED
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
Ovarian NeoplasmsUnlock trial analytics
PHASE2COMPLETED
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)

Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.

Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4
Baseline to Week 4

Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.

To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530
Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose
To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation.
Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.
The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test.
Assessed on an ongoing basis after starting daily dosing with AZD0530
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
Assessed at each visit

Secondary Endpoints

Progression-free Survival (PFS) as Evaluated by RECIST
Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)
Overall Survival (Number of Deaths)
Date of randomization to death due to any cause
Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4
Baseline to Week 4
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active ComparatorACTIVE_COMPARATORcarboplatin plus paclitaxel
2EXPERIMENTALAZD0530 in combination with carboplatin plus paclitaxel
AZD0530 175 mgEXPERIMENTALAZD0530 (saracatinib) 175 mg once daily
Zoledronic Acid 4 mgEXPERIMENTALZoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1EXPERIMENTAL -
3EXPERIMENTALAZD0530 + Carboplatin + Paclitaxel

Interventions

NameTypeDescription
AZD0530DRUGoral once daily dose
CarboplatinDRUGintravenous injection
PaclitaxelDRUGintravenous infusion
Zoledronic AcidDRUG -
[14C] AZD0530DRUGSolution, Oral, once
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Have a diagnosis of advanced ovarian cancer * Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy * Estimated life expectancy of more than 12 weeks Exclusion Criteria: * Central Ner...

Countries:BulgariaCanadaDenmarkFranceNetherlandsNorwayPeruPortugalRomaniaRussiaSpainUnited KingdomUnited StatesSwedenJapan
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 402 trials

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
Unlock Competitive Intelligence

Frequently asked questions about AZD0530

What is AZD0530 used for?

AZD0530 is an investigational small molecule being studied in oncology. Clinical trials have evaluated it in patients with breast cancer, prostate cancer with metastatic bone disease, solid tumors, and ovarian neoplasms. It has also been studied in healthy volunteers for formulation and metabolism research.

Who makes AZD0530?

AZD0530 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of the drug across multiple countries including the United States, Canada, Japan, and several European nations.

What phase is AZD0530 in?

AZD0530 has completed Phase 2 clinical development. A Phase 2 trial in breast and prostate cancer patients with metastatic bone disease has been completed, along with Phase 1 studies in solid tumors and healthy volunteers. The drug remains investigational and is not approved.

What clinical trials is AZD0530 in?

AZD0530 has been studied in several completed trials. NCT00558272 was a Phase 2 study in breast and prostate cancer with metastatic bone disease. NCT00704366 was a Phase 1 study in Japanese patients with solid tumors. NCT00771979 and NCT00853983 were Phase 1 studies in healthy volunteers.

Is AZD0530 the same as saracatinib?

AZD0530 is also known as saracatinib. Clinical trial records reference the drug under the AZD0530 name, and it has been investigated as an oral agent in oncology settings including breast cancer, prostate cancer, and solid tumors.