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PARP Inhibitor

AZD2281 for Ovarian Cancer

Phase 2

Waitlist Available

Led By Prof Jonathan A Lederman

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for ca-125 measurements, assessed maximum up to 14 months.

Awards & highlights

Study Summary

This trial is testing if a drug called AZD2281 can help keep cancer from growing after chemotherapy.

Who is the study for?

This trial is for women with serous ovarian cancer who've had a good response to at least two platinum-based chemo treatments. They should be within 8 weeks of their last chemo dose and haven't used PARP inhibitors like AZD2281 before.Check my eligibility

What is being tested?

The study tests if AZD2281 can keep ovarian cancer from getting worse after successful chemotherapy. Participants will either receive AZD2281 or a placebo, which is a treatment that looks the same but has no active drug.See study design

What are the potential side effects?

Possible side effects of AZD2281 may include nausea, fatigue, blood cell count changes leading to increased infection risk, and gastrointestinal issues. The exact side effects will vary among individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])

Secondary outcome measures

Best Objective Response

Best Percentage Change in Cancer Antigen 125 (CA-125) Levels

Disease Control Rate

+12 more

Side effects data

From 2018 Phase 2 trial • 97 Patients • NCT00628251

59%

Nausea

38%

Abdominal Pain

38%

Fatigue

34%

Vomiting

28%

Constipation

25%

Diarrhoea

25%

Headache

19%

Asthenia

19%

Cough

16%

Upper Respiratory Tract Infection

16%

Decreased Appetite

16%

Dyspepsia

16%

Urinary Tract Infection

16%

Dysgeusia

16%

Leukopenia

13%

Hot Flush

13%

Anaemia

13%

Oropharyngeal Pain

Rash

Back Pain

Arthralgia

Alopecia

Abdominal Distension

Influenza

Insomnia

Myalgia

Hypomagnesaemia

Muscle Spasms

Musculoskeletal Pain

Cerebrovascular Accident

Thrombocytopenia

Viral Infection

Hypotension

Nasopharyngitis

Weight Decreased

Flatulence

Oedema Peripheral

Flank Pain

Dizziness

Neuropathy Peripheral

Memory Impairment

Ascites

Neutropenia

Anxiety

Dyspnoea

Myelodysplastic Syndrome

Dry Skin

Intestinal Obstruction

Musculoskeletal Chest Pain

Bronchitis

Haemorrhoids

Pyrexia

Gastrooesophageal Reflux Disease

Syncope

Abdominal Pain Upper

Body Temperature Increased

Pain In Extremity

Groin Pain

Oral Pain

Pollakiuria

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 200 mg bd

Olaparib 400 mg bd

Liposomal Doxorubicin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1Experimental Treatment1 Intervention

AZD2281

Group II: 2Placebo Group1 Intervention

matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD2281

2008

Completed Phase 2

~560

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,521 Total Patients Enrolled

47 Trials studying Ovarian Cancer

23,585 Patients Enrolled for Ovarian Cancer

Prof Jonathan A LedermanPrincipal InvestigatorUniversity College, London

Mika Sovak, BSc, MBCHB, MDStudy DirectorAstraZeneca

Media Library

AZD2281 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00753545 — Phase 2

Ovarian Cancer Research Study Groups: 1, 2

Ovarian Cancer Clinical Trial 2023: AZD2281 Highlights & Side Effects. Trial Name: NCT00753545 — Phase 2

AZD2281 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00753545 — Phase 2

Frequently Asked Questions

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

Has the efficacy of AZD2281 been explored in any other research?

"To date, 188 clinical trials have been conducted to assess the efficacy of AZD2281. Presently, 27 studies are in Phase 3 and a total of 9250 locations across Houston, Texas are running these tests."

Answered by AI

What potential risks do patients face when taking AZD2281?

"Data collected thus far has led our team to rate the safety of AZD2281 a 2 on the 1-3 scale. As this is only at Phase 2, there are some promising results but no proof that it meets desired efficacy endpoints."

Answered by AI

How many venues are currently hosting this experiment?

"Currently, this medical trial is being administered at 14 distinct sites. These locations span across the United States and include Boston, Los Angeles and West Palm Beach among others. To minimise travel demands associated with participation in the study, it is advisable to pick a site nearby you."

Answered by AI

What condition is AZD2281 commonly prescribed to address?

"AZD2281 has been clinically proven to treat advanced directives, malignant neoplasm of ovary, primary peritoneal cancer and somatic hallucinations."

Answered by AI

How many participants have signed up for this research endeavor?

"This medical trial is no longer accepting applicants. It was first announced on August 28th 2008, and the most recent amendment to its details occurred on October 4th 2022. For those seeking other trials, there are currently 913 investigations recruiting participants with ovarian cancer while 188 studies require volunteers for AZD2281 research."

Answered by AI

Are there any open enrollment opportunities for this experiment?

"This trial has closed its recruitment period as of October 4th 2022. Thus, any interested parties must look to other clinical trials; with 913 studies actively seeking patients suffering from ovarian cancer and 188 related to AZD2281."

Answered by AI

Is this a pioneering endeavor in the medical field?

"Currently, 188 AZD2281 trials are taking place across 59 countries and 1468 cities. The original trial for this drug was funded by AstraZeneca in 2005; it featured 98 patients and culminated with the completion of Phase 1 clinical approval. Since then, 81 more trials have been concluded."

Answered by AI

Is this investigation accepting applicants aged 35 or older?

"In accordance with the eligibility criteria for this clinical trial, prospective participants must be 18 years of age or above, and not exceed 130."

Answered by AI

Could I be considered as a potential participant in this experiment?

"To be eligible for this clinical study, applicants must have been diagnosed with ovarian cancer and meet the age requirements of 18 to 130 years old. As of now, 265 people are being recruited."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Overall Survival in Patients with Platinum-sensitive Recurrent Serous Ovarian Cancer Receiving Olaparib Maintenance Monotherapy: An Updated Analysis from a Randomised, Placebo-controlled, Double-blind, Phase 2 Trial

Ledermann, Jonathan A, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare Scott, et al.. 2016. “Overall Survival in Patients with Platinum-sensitive Recurrent Serous Ovarian Cancer Receiving Olaparib Maintenance Monotherapy: An Updated Analysis from a Randomised, Placebo-controlled, Double-blind, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(16)30376-x.

brcaJournal

Olaparib Maintenance Therapy in Patients with Platinum-sensitive, Relapsed Serous Ovarian Cancer and A<i>brca</i>mutation: Overall Survival Adjusted for Postprogression Poly(adenosine Diphosphate Ribose) Polymerase Inhibitor Therapy

Matulonis, Ursula A., Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare Scott, et al.. 2016. “Olaparib Maintenance Therapy in Patients with Platinum-sensitive, Relapsed Serous Ovarian Cancer and Abrcamutation: Overall Survival Adjusted for Postprogression Poly(adenosine Diphosphate Ribose) Polymerase Inhibitor Therapy”. Cancer. Wiley. doi:10.1002/cncr.29995.

Nature Reviews CancerJournal

Beyond Chemotherapy: Targeted Therapies in Ovarian Cancer

Yap, Timothy A., Craig P. Carden, and Stan B. Kaye. 2009. “Beyond Chemotherapy: Targeted Therapies in Ovarian Cancer”. Nature Reviews Cancer. Springer Science and Business Media LLC. doi:10.1038/nrc2583.

The Lancet OncologyJournal