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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
Subjects must have histologically or cytologically confirmed diagnosis of primary or recurrent metastatic melanoma including cutaneous, mucosal, or uveal melanoma
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.
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You have a disease that can be measured using specific criteria called RECIST 1.1.
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You have been treated with a type of medication called a checkpoint inhibitor before.
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You are 18 years old or older.
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You must have a disease that can be measured using specific criteria.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and defined as the time from start of treatment to the date of death due to any cause 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
Overall response rate (ORR)
Secondary outcome measures
Disease Control Rate
Number of participants with treatment-related adverse events
Overall Survival
+1 more

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%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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%
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%
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%
General physical health deterioration
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
~2140

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,364 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,237 Previous Clinical Trials
288,449,675 Total Patients Enrolled
Tamara Sussman, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05482074 — Phase 2
Skin Cancer Research Study Groups: OLAPARIB
Skin Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT05482074 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05482074 — Phase 2

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
~0 spots leftby May 2026