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PI3K Inhibitor

Olaparib for Ovarian Cancer

Phase 2

Waitlist Available

Led By Panagiotis A Konstantinopoulos

Research Sponsored by National Cancer Institute (NCI)

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 up to 5 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat ovarian, fallopian tube, or primary peritoneal cancer that has come back and did not respond to previous platinum-based chemotherapy.

Eligible Conditions

Peritoneal Carcinoma
Ovarian Cancer
Fallopian Tube Carcinoma
Endometrioid Adenocarcinoma
Peritoneal Adenocarcinoma
Ovarian Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Progression free survival (PFS)

Secondary outcome measures

Incidence of adverse events

Objective response rate (ORR)

Overall survival (OS)

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

Nausea

47%

Fatigue

38%

Diarrhoea

29%

Abdominal pain

29%

Anaemia

28%

Constipation

27%

Decreased appetite

27%

Back pain

26%

Vomiting

21%

Arthralgia

19%

Pyrexia

18%

Asthenia

13%

Rash

13%

Nasopharyngitis

11%

Alanine aminotransferase increased

11%

Dyspnoea

10%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Hyperglycaemia

Aspartate aminotransferase increased

Dizziness

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (copanlisib, olaparib)Experimental Treatment4 Interventions

Patients receive copanlisib hydrochloride IV and olaparib PO while on study. Patients undergo CT scan while on study and may undergo MRI throughout the study.

Group II: Arm I (standard of care chemotherapy)Active Control5 Interventions

Patients receive either paclitaxel IV OR pegylated liposomal doxorubicin hydrochloride IV, OR topotecan hydrochloride IV while on study. Patients undergo CT scan while on study and may undergo MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

Olaparib

2007

Completed Phase 4

~2140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,766 Patients Enrolled for Ovarian Cancer

NRG OncologyOTHER

231 Previous Clinical Trials

100,852 Total Patients Enrolled

Panagiotis A KonstantinopoulosPrincipal InvestigatorNRG Oncology

2 Previous Clinical Trials

98 Total Patients Enrolled

Frequently Asked Questions

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

How many people are going to participate in this experiment?

"In order to carry out this clinical trial, 96 individuals who match the given criteria are required. These potential participants can be from various locations, such as University of Oklahoma Health Sciences Center or Women and Infants Hospital."

Answered by AI

Are there any current vacancies for participants in this trial?

"The trial is presently recruiting participants, with the most recent update occurring on 9/2/2022. The trial was initially posted on 6/30/2022."

Answered by AI

What are the dangers associated with Olaparib treatments?

"While there is some data to support the safety of Olaparib, it only received a score of 2 because there is no evidence yet demonstrating its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy

2022. "Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295589.