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PARP Inhibitor
Olaparib for Melanoma
Phase 2
Waitlist Available
Led By Tamara Sussman, MD
Research Sponsored by Dana-Farber Cancer Institute
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 defined as the time from start of treatment to the date of death due to any cause up to 5 years
Awards & highlights
Study Summary
This trial is testing the effectiveness of Olaparib as a treatment for patients with primary or recurrent, unresectable or metastatic melanoma. Olaparib is a targeted therapy drug.
Who is the study for?
This trial is for adults with unresectable or metastatic melanoma, including skin, mucosal, or uveal types. They must have a BRCA1/2 mutation and have previously received checkpoint inhibitor therapy. Participants need to be able to take pills orally, have measurable disease by RECIST 1.1 criteria, and an ECOG status ≤1. Pregnant women, those with recent chemotherapy or radiotherapy for melanoma, known HIV/AIDS-related illness or active hepatitis are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Olaparib (Lynparza), a targeted therapy drug for treating primary or recurrent metastatic melanoma in patients who've had prior checkpoint inhibitor therapy. It's designed to see how well this medication works on different types of melanoma when other treatments haven't been effective.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, vomiting, fatigue, anemia (low red blood cell counts), neutropenia (low white blood cell counts), which can increase infection risk; thrombocytopenia (low platelet counts); and potential allergic reactions to its ingredients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ defined as the time from start of treatment to the date of death due to any cause up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~defined as the time from start of treatment to the date of death due to any cause 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
Disease Control Rate
Number of participants with treatment-related adverse events
Overall Survival
+1 moreSide 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
1Treatment groups
Experimental Treatment
Group I: OLAPARIBExperimental Treatment1 Intervention
The research study procedures include screening for eligibility, study treatment including evaluations, surveys, optional biopsies, and follow up visits
Olaparib- Each study treatment cycle lasts 28 days . This will continue for as long as the study treatment is providing clinical benefit
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,934 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,275 Previous Clinical Trials
288,613,601 Total Patients Enrolled
Tamara Sussman, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had chemotherapy or radiotherapy for melanoma within the last 3 weeks before joining the study.You have a spinal cord compression and have not completed treatment for it at least 28 days ago.You are taking certain medications that can interact with the study drug.You have HIV or AIDS.You have a current, active Hepatitis B or C infection.You have been diagnosed with advanced melanoma, which includes skin, mucous membrane, or eye melanoma and it has been confirmed by a tissue or cell sample test.You must have a specific genetic mutation in the BRCA1 or BRCA2 genes from certain test providers.You have myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) or symptoms that suggest MDS or AML.You are taking strong or moderate CYP3A inducers.You have received a medication called a PARP inhibitor, like olaparib, in the past.Your heart test shows a serious, but fixable, problem.You can participate in the trial if you have had or currently have another type of cancer that won't affect the safety or effectiveness of the study treatment.You have had a specific type of bone marrow transplant in the past.You are allergic to olaparib or any of the ingredients in the product.You have a disease that can be measured using specific criteria called RECIST 1.1.You are still experiencing side effects from previous cancer treatments, except for hair loss.You have had another type of cancer, but it has been completely treated and hasn't come back for at least 5 years.You are 18 years old or older.You have brain metastases that are causing symptoms and are not under control.You have been treated with a type of medication called a checkpoint inhibitor before.You must have a disease that can be measured using specific criteria.You are able to perform daily activities without any major limitations.
Research Study Groups:
This trial has the following groups:- Group 1: OLAPARIB
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.
What risks and side effects must be taken into account when considering Olaparib as a treatment?
"Olaparib's safety rating was assessed as a 2, reflecting the lack of evidence for efficacy but some data indicating it is relatively secure."
Answered by AI
Is enrollment currently open for this scientific experiment?
"This clinical trial is now closed-off to new enrolment, as evidenced by the data hosted on clinicialtrials.gov; initial posting was dated February 1st 2023 and the final edit was made July 29th 2022. However, those interested in participating can explore 762 other studies that are currently recruiting patients."
Answered by AI
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