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PARP Inhibitor

Olaparib for Solid Tumors

Phase 2
Recruiting
Led By Patricia M LoRusso
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
ANC >= 1.5 x 10^9/L
No previous treatment with the specific assigned study drug or any other PARP inhibitor
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will study how well olaparib works in treating patients with certain types of cancer that have spread and usually cannot be controlled with treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Cancer
  • Glioblastoma
  • Cholangiocarcinoma
  • Solid Tumors
  • Low Grade Glioma
  • Gliomas
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are expected to live for at least 16 weeks.
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Your tumor must be easy to reach for biopsy, and you must be willing to undergo multiple biopsies.
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If you have cancerous growths outside of your brain, there must be at least one that can be easily measured or examined.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Incidence of adverse events
Progression-free survival
Other outcome measures
Plasma
2HG plasma magnetic resonance spectroscopy levels
Dysgeusia

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%
Dyspnoea
11%
Alanine aminotransferase increased
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Thrombocytopenia
9%
Dizziness
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
9%
Aspartate aminotransferase increased
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Bladder papilloma
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib)Experimental Treatment5 Interventions
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and/or MRI, as well as a tumor biopsy and blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1160
Biospecimen Collection
2004
Completed Phase 1
~1540
Computed Tomography
2017
Completed Phase 2
~2890
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Olaparib
2017
Completed Phase 4
~1270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,489 Previous Clinical Trials
41,266,536 Total Patients Enrolled
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
197 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03212274 — Phase 2
Cancer Research Study Groups: Treatment (olaparib)
Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03212274 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03212274 — Phase 2

Frequently Asked Questions

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

What supplementary investigations have been performed utilizing Olaparib?

"Olaparib first underwent clinical trials in 2005 at Research Site, with 63 studies having been completed since. Currently, 188 active trials are being carried out across the United States of America - many of which originated from Overland Park, Kansas."

Answered by AI

How many subjects are being included in this medical research?

"In order to complete the study, 145 eligible participants are needed. The research will take place at two University of Kansas locations: Hospital-Indian Creek Campus in Overland Park and Westwood Cancerf Kansas locations: Hospital-Indian Creek Campus in Overland Park and Westwood Cancer Center in Westwood."

Answered by AI

Is this experiment pathbreaking in its approach?

"Olaparib has been under clinical study since 2005, with the first trial sponsored by AstraZeneca. After its Phase 1 approval in 2005 following a 98-patient sample size evaluation, there are presently 188 ongoing trials of Olaparib spread over 1468 cities and 59 countries worldwide."

Answered by AI

In what quantity of medical establishments is this experiment being conducted?

"This clinical trial is currently being offered from 34 different sites, including Overland Park, Westwood and Nashville. To reduce the need for long-distance travel during your participation in this study, we recommend selecting a site close to you."

Answered by AI

Are new participants being enrolled in this medical experiment?

"Affirmative. According to the clinical trials website, this medical experiment is currently recruiting participants. Initially posted on March 30th 2018 and most recently updated October 18th 2022, 145 patients are needed from 34 sites across the country."

Answered by AI

To what extent can patients rely on Olaparib to be secure?

"The safety rating for Olaparib was 2, as the Phase 2 trial has yet to produce any evidence of efficacy. This score is based on existing data that points towards its safety."

Answered by AI

What pathologies can be ameliorated through the utilization of Olaparib?

"Olaparib is used to treat a range of maladies, including advance directives and the cancerous growths in the ovary or peritoneum. Additionally, it can be effective against hallucinations, somatic."

Answered by AI
~18 spots leftby Jul 2024