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PARP Inhibitor
Olaparib for Bladder Cancer
Phase 2
Recruiting
Led By Andrea B Apolo
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
Ability to understand and the willingness to sign a written informed consent document or patients with impaired decision making capacity (IDMC) if they are represented by a legally authorized representative (LAR)
Patients must have Clinical Laboratory Improvement Act (CLIA) testing and fit one of the following groups: Confirmed presence of a cancer-associated alteration considered pathogenic/likely pathogenic by FM and/or the Genetics Review Panel in specified genes or in one or more of the DNA-repair genes tested in the FoundationOne FoundationOneCDx (F1CDx) panel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing olaparib, a PARP inhibitor, to treat patients with advanced or metastatic bladder cancer or other genitourinary tumors.
Who is the study for?
Adults with advanced bladder cancer or genitourinary tumors that have DNA-repair defects and can't be cured by standard treatments. Participants must have specific genetic changes, provide a tumor sample, not be pregnant or fathering children, and meet certain health criteria like good organ function and blood counts.Check my eligibility
What is being tested?
The trial is testing Olaparib, a PARP inhibitor designed to prevent cancer cells from repairing their DNA, potentially stopping their growth. It's for patients whose cancer has spread and involves collecting biospecimens to study the treatment's effectiveness.See study design
What are the potential side effects?
Olaparib may cause side effects such as nausea, fatigue, anemia (low red blood cell count), vomiting, diarrhea, loss of appetite, taste changes, indigestion or heartburn. 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 belowSelect...
I can understand and am willing to sign the consent form, or I have someone legally authorized to do so on my behalf.
Select...
My tests show a genetic change linked to cancer.
Select...
My cancer can be measured and has been treated with platinum-based chemotherapy or immune therapy.
Select...
My cancer diagnosis was confirmed through tissue examination.
Select...
I am 18 years old or older.
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I can take pills and don't have stomach issues that affect medicine absorption.
Select...
I can provide a previous tumor sample or am willing to have a biopsy for testing.
Select...
I am postmenopausal or cannot become pregnant.
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I am fully active or able to carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 (ORR)
Secondary outcome measures
Incidence of adverse events
DNA
Progression free survival (PFS)
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
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
2Treatment groups
Experimental Treatment
Group I: Cohort II (biospecimen collection)Experimental Treatment1 Intervention
Patients that do not have cancer-associated DNA-repair gene mutations undergo blood sample collection at baseline.
Group II: Cohort I (olaparib)Experimental Treatment1 Intervention
Patients that have cancer-associated DNA-repair gene mutations receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,926,048 Total Patients Enrolled
Andrea B ApoloPrincipal InvestigatorNational Cancer Institute LAO
3 Previous Clinical Trials
1,115 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and am willing to sign the consent form, or I have someone legally authorized to do so on my behalf.My genetic test shows benign or uncertain results.You have had allergic reactions to drugs similar to olaparib.My tests show a genetic change linked to cancer.My cancer can be measured and has been treated with platinum-based chemotherapy or immune therapy.Your total bilirubin level should not be higher than 1.5 times the upper limit of normal. If you have Gilbert's disease, your total bilirubin level should not be higher than 3.0 mg/dL.Your blood clotting tests should be within a certain range, unless you have a confirmed condition or are taking specific medications for blood clotting.I am willing and able to follow the study's requirements, including treatments and visits.My cancer diagnosis was confirmed through tissue examination.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have lasting side effects from cancer treatment, except for hair loss.I have brain metastases.I am 18 years old or older.I have a long-term or recent liver disease.I have not had a stroke, TIA, or heart attack in the last 6 months.I have not had any other cancer in the last 5 years.My ECG shows a QTc of more than 470 msec or I have a family history of long QT syndrome.I do not have any uncontrolled diseases or illnesses.I can take pills and don't have stomach issues that affect medicine absorption.I can provide a previous tumor sample or am willing to have a biopsy for testing.My hemoglobin level is at least 10 g/dL, transfusions included.Your platelet count is at least 100,000 per microliter.I am not taking drugs that affect CYP3A enzyme activity.You have a weakened immune system, for example, if you have HIV.You are taking any other experimental medications.I am postmenopausal or cannot become pregnant.I do not have active hepatitis B or C.Your kidneys work well enough to clear out waste from your body.Your absolute neutrophil count is at least 1,500 per microliter.I am fully active or able to carry out light work.I have had a bone marrow or double cord blood transplant.Your white blood cell count is at least 3,000 per microliter.I have not had major surgery in the last 2 weeks.Your liver enzymes (AST and ALT) are not too high, unless you have cancer that has spread to the liver, in which case they can be a little higher.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I have previously been treated with olaparib or another PARP inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (olaparib)
- Group 2: Cohort II (biospecimen collection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 being included in this research project?
"Yes, the information on clinicaltrials.gov verifies that this trial is still ongoing and actively recruiting patients. The study was originally posted on August 3rd, 2018 and updated September 21st, 2020. They are looking for a total of 60 participants from 3 different locations."
Answered by AI
What are some of the precedent-setting investigations that have been carried out with Olaparib?
"Originally, olaparib was studied in 2005 at a single research site. As of now, 70 trials have been completed while 198 are still active. Out of these active studies, many are being conducted near Bethesda, Maryland."
Answered by AI
Has a study like this been done before?
"2005 was the starting point for olaparib's clinical trials. The first one was completed that year and sponsored by AstraZeneca. After Phase 1 approval, there are now 198 active trials in 1462 cities and 59 countries."
Answered by AI
What are the dangers associated with Olaparib?
"While there is some evidence suggesting that Olaparib is safe for human use, it only received a score of 2 because this Phase 2 trial has yet to produce data affirming the drug's efficacy."
Answered by AI
Are people currently being accepted into this program?
"Yes, the clinical trial is currently recruiting patients as indicated by the listing on clinicaltrials.gov. This particular study was posted on 8/3/2018 and last updated 9/21/2022. They are seeking a total of 60 participants across 3 different locations."
Answered by AI
What condition does Olaparib usually help alleviate?
"Olaparib is the standard treatment for advance directives, and can also help patients manage somatic hallucinations, primary peritoneal cancer, and malignant neoplasms of the ovary."
Answered by AI
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