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PARP Inhibitor

AZD2281 for Ovarian Cancer

Phase 2
Waitlist Available
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 each patient with measurable disease at baseline was assessed for best percentage change in tumour size 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.
Awards & highlights

Study Summary

This trial is testing a new drug for breast and ovarian cancer in both people with and without the BRCA mutation. They're hoping to find out if the drug is effective and to identify any early markers of activity.

Eligible Conditions
  • Ovarian Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
Secondary outcome measures
Best Percentage Change From Baseline in Tumour Size
CA-125 Levels (Ovarian Cancer Patients Only)
Disease Control Rate (DCR)
+2 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
9%
Rash
9%
Back Pain
9%
Arthralgia
9%
Alopecia
9%
Abdominal Distension
9%
Influenza
9%
Insomnia
6%
Myalgia
6%
Hypomagnesaemia
6%
Muscle Spasms
6%
Musculoskeletal Pain
6%
Cerebrovascular Accident
6%
Thrombocytopenia
6%
Viral Infection
6%
Hypotension
6%
Nasopharyngitis
6%
Weight Decreased
6%
Flatulence
6%
Oedema Peripheral
6%
Flank Pain
6%
Dizziness
6%
Neuropathy Peripheral
6%
Memory Impairment
6%
Ascites
6%
Neutropenia
6%
Anxiety
6%
Dyspnoea
3%
Myelodysplastic Syndrome
3%
Dry Skin
3%
Intestinal Obstruction
3%
Musculoskeletal Chest Pain
3%
Bronchitis
3%
Haemorrhoids
3%
Pyrexia
3%
Gastrooesophageal Reflux Disease
3%
Syncope
3%
Abdominal Pain Upper
3%
Body Temperature Increased
3%
Pain In Extremity
3%
Groin Pain
3%
Oral Pain
3%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 200 mg bd
Olaparib 400 mg bd
Liposomal Doxorubicin

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4Experimental Treatment1 Intervention
Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Group II: 3Experimental Treatment1 Intervention
High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Group III: 2Experimental Treatment1 Intervention
Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Group IV: 1Experimental Treatment1 Intervention
Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2281
2008
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,576 Total Patients Enrolled
48 Trials studying Ovarian Cancer
23,711 Patients Enrolled for Ovarian Cancer
British Columbia Cancer AgencyOTHER
171 Previous Clinical Trials
90,412 Total Patients Enrolled
6 Trials studying Ovarian Cancer
371 Patients Enrolled for Ovarian Cancer
Karen Gelmon, MDStudy ChairBritish Columbia Cancer Agency

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Annals of OncologyJournal
Olaparib Monotherapy in Patients with Advanced Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation: A Multistudy Analysis of Response Rates and Safety
Matulonis, U.A., R.T. Penson, S.M. Domchek, B. Kaufman, R. Shapira-Frommer, M.W. Audeh, S. Kaye, et al.. 2016. “Olaparib Monotherapy in Patients with Advanced Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation: A Multistudy Analysis of Response Rates and Safety”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdw133.
clinicaltrials.govStudy
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
2008. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00679783.
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