← Back to Search

PARP Inhibitor

Olaparib for Bladder Cancer

Phase 2
Waitlist Available
Led By Matthew Galsky, MD
Research Sponsored by Matthew Galsky
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 time of treatment start until death or date of last contact, up to a maximum of 23 months.
Awards & highlights

Study Summary

This trial is testing a new cancer drug for people with metastatic urothelial cancer. The drug is olaparib and it is given as a monotherapy (just this one drug, not in combination with any others). The objective of the study is to see what the response rate is to the drug in this population.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of treatment start until death or date of last contact, up to a maximum of 23 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of treatment start until death or date of last contact, up to a maximum of 23 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
Objective Response Rate (ORR)
Secondary outcome measures
Progression-Free Survival (PFS)
Other outcome measures
Adverse Events
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
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
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%
General physical health deterioration
1%
Bladder papilloma
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%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Olaparib MonotherapyExperimental Treatment1 Intervention
The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of > 30 to < 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

Matthew GalskyLead Sponsor
10 Previous Clinical Trials
402 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
858 Previous Clinical Trials
524,267 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,883 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03448718 — Phase 2
Bladder Cancer Research Study Groups: Olaparib Monotherapy
Bladder Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03448718 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03448718 — Phase 2

Frequently Asked Questions

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

What adverse effects have been linked to Olaparib usage?

"The safety of Olaparib was evaluated as a 2 on the risk-scale, indicating that although some evidence for its security exists, there is yet to be any proof of efficacy."

Answered by AI

Is this a pioneering research project?

"Olaparib's journey began in 2005 with a trial sponsored by AstraZeneca, which comprised of 98 patients. Eventually this drug secured its Phase 1 approval and is currently being evaluated across 59 countries and 1468 cities, involving 188 ongoing studies."

Answered by AI

Is there presently an opportunity for patients to partake in this research?

"Clinicaltrials.gov shows that this research is no longer actively recruiting patients, despite being initially posted on April 17th 2018 and updated as recently as July 7th 2022. However, 193 other trials are currently in need of participants."

Answered by AI

What illnesses has Olaparib been demonstrated to be effective in treating?

"Olaparib can be an effective treatment for advance directives, ovarian cancer, and primary peritoneal carcinoma."

Answered by AI

How many locations are currently executing this research trial?

"This research study is being conducted in various sites, including Vanderbilt-Ingram Cancer Center of Nashville, Tennessee; Johns Hopkins Sidney Kimmel Comprehensive Cancer Centre of Baltimore Maryland and Huntsman Cancer Institute University of Utah located in Salt Lake City."

Answered by AI

Has Olaparib been explored in other scientific investigations?

"Presently, there are 27 Olaparib trials running in Phase 3 and 188 total studies for this medication. Most of the research is taking place within Houston but patients can find assistance at over 9250 other locations across the country."

Answered by AI

How many participants have joined the trial to date?

"Patient recruitment for this trial has ceased; it debuted on April 17th 2018 and was last modified July 7th 2022. Patients may consider the 5 trials presently enrolling individuals with metastatic urothelial cancer or the 188 studies utilizing Olaparib as treatment options."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
Matthew Galsky 2018. "Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03448718.
~3 spots leftby Apr 2025
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.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top