Recent Updates
Recently added Catalysts

AZD2281

Phase 2

Ovarian Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 6, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment265

FDA Designations

No designations recorded

Clinical trial landscape

AZD2281 · 8 trials · 9 indications

Phase 2 3Phase 1 5
NCT00753545Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian CancerOvarian Cancer
COMPLETED265 Analytics
NCT00628251Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian CancerOvarian Neoplasms
COMPLETED97 Analytics
NCT00679783Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast CancerOvarian Carcinoma
COMPLETED99 Analytics
PHASE2COMPLETED
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
Ovarian NeoplasmsUnlock trial analytics
PHASE2COMPLETED
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
Ovarian CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.

PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]

Progression Free Survival (PFS)
Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.

Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.

To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.
Weekly visits for routine monitoring visits
PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation
Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose
Continued Supply Phase: To enable patients to continue to receive treatment with AZD2281. Safety and tolerability data will be collected to further determine the safety and tolerability of the capsule formulation of AZD2281 in these patients
every 28 days
Continued Supply Expansion Phase: To compare the safety and tolerability of the tablet and capsule formulation of AZD2281 in all patients: Safety, AEs, Physical Exam, vital signs
at every visit
Dose Escalation Phase of continued supply expansion: To determine safety & tolerability of higher than 200mg bid (to 400mg) of tablet & compare safety & tolerability profile of tablet with 400mg capsule
at every visit
Randomised tablet formulation continued supply expansion phase (Group 8): To determine the safety and tolerability profile of selected tablet dose schedules of the melt-extrusion (tablet) formulation.
at every visit
Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study
safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam
various timepoints.
To characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours, assessed by blood, urine and faecal sampling
Various timepoints

Secondary Endpoints

Overall Survival (OS)
Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Objective Response Rate (ORR) (According to RECIST)
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Disease Control Rate
Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD2281
2PLACEBO_COMPARATORmatching placebo
3EXPERIMENTALAZD2281 Oral 400 mg BID
4EXPERIMENTALKnown BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Treatment AEXPERIMENTAL300mg bid (twice daily) tablet dose
Treatment BEXPERIMENTAL400 mg twice daily (bid) capsule dose
Treatment CEXPERIMENTAL400mg bid (twice daily) tablet dose

Interventions

NameTypeDescription
AZD2281DRUGTablets Oral BID
matching placeboDRUGmatching placebo bid
Liposomal DoxorubicinDRUG50mg/m2 Monthly Intravenous
CisplatinDRUGIV every 3 weeks
PaclitaxelDRUGIntravenous infusion over 1 hour
BevacizumabDRUGIV administration10 mg/kg every 14 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 130 Years
SexFEMALE
Healthy VolunteersNo
Study Sites107

Inclusion Criteria: * Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer. * Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen. * ...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaEstoniaFranceGermanyIsraelNetherlandsPolandRomaniaRussiaSpainUkraineUnited KingdomSwedenSwitzerland
Unlock Eligibility Criteria

Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
Unlock Competitive Intelligence

Recent Changes (Last 90 Days)

LOWAug 6, 2026NCT00777582lastUpdatePostDate: changed
LOWAug 6, 2026NCT00777582lastUpdatePostDate: changed

Frequently asked questions about AZD2281

What is AZD2281 used for?

AZD2281 is an investigational small molecule being studied in oncology for ovarian carcinoma, solid tumors, breast cancer, advanced solid tumors, ovarian neoplasms, and neoplasm metastasis. It is in clinical development and has not been approved by regulatory authorities.

Who makes AZD2281?

AZD2281 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.

What phase is AZD2281 in?

AZD2281 is in Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical evaluation for safety and effectiveness.

What clinical trials is AZD2281 in?

AZD2281 has been studied in several trials, including NCT00633269, a Phase 1 study in patients with solid metastatic tumors; NCT00679783, a Phase 2 study in ovarian cancer and breast cancer; NCT00707707, a Phase 1/2 study in metastatic triple negative breast cancer; and NCT00777582, a Phase 1 bioavailability study in solid tumors.

How does AZD2281 work?

AZD2281 is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works by blocking PARP enzymes, which are involved in DNA repair, potentially leading to cancer cell death, particularly in tumors with BRCA mutations.