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AZD0530

Phase 2

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

AZD0530 development status

Highest phase Phase 2
Registered trials 8 across 2 sponsors since May 2007

AZD0530 target and mechanism

ModalitySmall molecule

Also known as [14C] AZD0530, Saracatinib

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials4
Total Enrollment516

FDA Designations

No designations recorded

AZD0530 clinical trials

AZD0530 · 4 trials · 7 indications

Phase 2 2Phase 1 2
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.

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
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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
1EXPERIMENTALAZD0530
3EXPERIMENTALAZD0530 + Carboplatin + Paclitaxel

Interventions

NameTypeDescription
AZD0530DRUGoral once daily dose
CarboplatinDRUGintravenous injection
PaclitaxelDRUGintravenous infusion
Zoledronic AcidDRUG -
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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
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Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about AZD0530

What is AZD0530?

AZD0530 is an investigational small molecule developed by AstraZeneca PLC for oncology indications. It has been studied in breast cancer, ovarian cancer, prostate cancer, solid tumors, and other neoplasms. The compound is also referred to as [14C] AZD0530 in some study contexts. It remains in clinical development and is not described as an approved therapy.

What is AZD0530 used for in ovarian cancer?

AZD0530 has been evaluated in a Phase 2 study of patients with advanced ovarian cancer, identified as NCT00610714. That trial enrolled 211 female participants aged 18 and older across multiple countries including Canada, the United Kingdom, Spain, and others. The study is completed. AZD0530 is investigational and not an approved treatment for ovarian cancer.

Who makes AZD0530?

AstraZeneca PLC develops AZD0530. The company trades under the ticker AZN. AstraZeneca sponsored the clinical studies of AZD0530 in solid tumors, ovarian cancer, breast cancer, and prostate cancer with metastatic bone disease.

What phase is AZD0530 in?

AZD0530 has reached Phase 2 clinical development. Completed studies include Phase 2 trials in advanced ovarian cancer and in breast and prostate cancer patients with metastatic bone disease, along with Phase 1 studies in solid tumors. AZD0530 is investigational and is not described as an FDA-approved product.

What clinical trials is AZD0530 in?

Completed AZD0530 trials include NCT00610714, a Phase 2 study in advanced ovarian cancer with 211 patients, NCT00558272, a Phase 2 study in breast and prostate cancer with metastatic bone disease, NCT00704366, a Phase 1 solid tumor study in Japan, and NCT00496028, a Phase 1 solid tumor study in Europe.

Is AZD0530 the same as [14C] AZD0530?

Yes, [14C] AZD0530 is an alternative name for AZD0530, referring to the carbon-14 labeled form of the compound used in study settings. Both names refer to the same AstraZeneca small molecule being investigated in oncology indications including breast cancer, ovarian cancer, and solid tumors.