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PARP Inhibitor

Olaparib for Ovarian Cancer

Phase 2
Recruiting
Research Sponsored by Alexander B Olawaiye, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal organ and marrow function as defined below: - Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L - Platelets ≥ 100 x 109 /L - Hemoglobin (Hgb) ≥ 8 g/dL (blood transfusions to reach this amount are allowed) - Serum creatinine ≤ 1.5 mg/dL - Total serum bilirubin ≤ 1.5 x ULN - AST and ALT ≤ 2.5 x ULN
Histologically confirmed advanced BRCAwt+ ovarian cancer with known recombinant deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, every 12 weeks during treatment, at end of treatment, up to 3 years
Awards & highlights

Study Summary

This trial tests if olaparib can help ovarian cancer patients with a specific genetic mutation after initial treatment.

Who is the study for?
This trial is for advanced ovarian cancer patients with BRCAwt and homologous recombination deficiency. Participants must have a good performance status, life expectancy over 16 months, normal organ/marrow function, measurable disease per RECIST 1.1 criteria, and no prior enrollment in this study or recent investigational drug use.Check my eligibility
What is being tested?
The trial tests the effectiveness of olaparib tablets as maintenance therapy following initial platinum-based treatment in these specific ovarian cancer patients. It's a prospective non-randomized study focusing on those without BRCA mutations but with homologous recombination deficiencies.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, fatigue, anemia (low red blood cell counts), vomiting, diarrhea, indigestion, headache, decreased appetite or taste changes. Some people might experience more serious issues like lung problems or blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood and organ functions are within normal ranges.
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My ovarian cancer is advanced, BRCA wild type, and has a specific genetic deficiency.
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I have a tumor that can be measured or monitored by scans.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, every 12 weeks during treatment, at end of treatment, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, every 12 weeks during treatment, at end of treatment, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1-year Progression-free Survival (PFS)
Time to progression (TTP)
Secondary outcome measures
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Overall Survival (OS)
Progression-free Survival (PFS)
+1 more

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT03106987
39%
Nausea
24%
Asthenia
18%
Fatigue
18%
Anaemia
14%
Diarrhoea
12%
Constipation
11%
Abdominal pain
11%
Vomiting
9%
Dyspnoea
9%
Abdominal pain upper
8%
Headache
7%
Cough
5%
Neutropenia
5%
Leukopenia
5%
Dizziness
5%
Blood creatinine increased
5%
Dry mouth
5%
Muscle spasms
4%
Alanine aminotransferase increased
4%
Dysgeusia
3%
Aspartate aminotransferase increased
3%
Influenza
3%
Skin infection
3%
COVID-19 pneumonia
3%
Urinary tract infection
3%
Lymphopenia
3%
Thrombocytopenia
3%
Decreased appetite
3%
Insomnia
3%
Paraesthesia
3%
Hot flush
3%
Hypertension
3%
Dyspepsia
3%
Flatulence
3%
Dry skin
3%
Back pain
3%
Platelet count decreased
3%
Contusion
3%
Blood urea increased
1%
Pleural infection
1%
Blood albumin decreased
1%
Neuropathy peripheral
1%
Sluggishness
1%
Genital herpes
1%
Fall
1%
Gingivitis
1%
Neurotoxicity
1%
Blood alkaline phosphatase increased
1%
Rash maculo-papular
1%
Radius fracture
1%
Gastroenteritis cryptosporidial
1%
Hypermagnesaemia
1%
Peripheral sensory neuropathy
1%
Tinnitus
1%
Musculoskeletal pain
1%
Cystitis
1%
Pyrexia
1%
Bronchitis
1%
COVID-19
1%
Sinusitis
1%
Oesophageal squamous cell carcinoma
1%
Hypothyroidism
1%
Hypercholesterolaemia
1%
Hypokalaemia
1%
Hypomagnesaemia
1%
Hyponatraemia
1%
Bell's palsy
1%
Sciatica
1%
Syncope
1%
Dry eye
1%
Eye irritation
1%
Vertigo
1%
Palpitations
1%
Tachycardia
1%
Hypotension
1%
Dysphonia
1%
Rhinorrhoea
1%
Aphthous ulcer
1%
Gastrooesophageal reflux disease
1%
Oropharyngeal pain
1%
Odynophagia
1%
Stomatitis
1%
Alopecia
1%
Pruritus
1%
Rash
1%
Flank pain
1%
Hypercreatinaemia
1%
Muscular weakness
1%
Myalgia
1%
Osteoporosis
1%
Illness
1%
Mucosal inflammation
1%
Oedema peripheral
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
1%
Weight decreased
1%
Bone pain
1%
Hypocalcaemia
1%
Arthritis
1%
Polyneuropathy
1%
Tremor
1%
Chest pain
1%
Creatinine renal clearance decreased
1%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib (BRCA1/2 +ve)
Placebo (BRCA1/2 +ve)
Olaparib (BRCA1/2 -ve)
Placebo (BRCA1/2 -ve)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Olaparib (maintenance)Experimental Treatment1 Intervention
300 mg Olaparib (tablets) will be taken orally, twice a day (approximately every twelve hours)

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Who is running the clinical trial?

Alexander B Olawaiye, MDLead Sponsor
AstraZenecaIndustry Sponsor
4,289 Previous Clinical Trials
288,620,118 Total Patients Enrolled
47 Trials studying Ovarian Cancer
23,631 Patients Enrolled for Ovarian Cancer
~53 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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