Olaparib for Cutaneous Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Cutaneous Melanoma+4 More
Olaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate how effective Olaparib is when given as a treatment for primary or recurrent, unresectable or metastatic melanoma. This research study involves targeted therapy. -The name of the study drug involved in this study is: Olaparib (also known as Lynparza)

Eligible Conditions

  • Melanoma, Uveal
  • Mucosal Melanoma
  • Cutaneous Melanoma
  • Recurrent Metastatic Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cutaneous Melanoma

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: defined as the time from start of treatment to the date of death due to any cause up to 5 Years

12 weeks
Overall response rate (ORR)
Year 5
Overall Survival
Year 2
Progression Free Survival
Year 2
Number of participants with treatment-related adverse events
Year 2
Disease Control Rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cutaneous Melanoma

Side Effects for

gBRCAm
56%Nausea
44%Fatigue
44%Anaemia
28%Vomiting
17%Diarrhoea
16%Dyspepsia
15%Asthenia
15%Dizziness
14%Neutropenia
13%Arthralgia
13%Headache
13%Abdominal pain
11%Decreased appetite
10%Nasopharyngitis
10%Abdominal pain upper
10%Dyspnoea
10%Cough
9%Dysgeusia
9%Blood creatinine increased
8%Alopecia
8%Influenza
8%Alanine aminotransferase increased
8%Back pain
8%Insomnia
8%Influenza like illness
7%Leukopenia
7%Abdominal distension
7%Pyrexia
7%Hypomagnesaemia
6%Peripheral swelling
6%Urinary tract infection
6%Platelet count decreased
6%White blood cell count decreased
6%Thrombocytopenia
6%Bronchitis
6%Neutrophil count decreased
6%Constipation
5%Depression
5%Anxiety
5%Myalgia
5%Musculoskeletal pain
5%Pain in extremity
5%Pruritus
3%Abdominal pain lower
3%Pulmonary embolism
3%Hypertension
3%Gastrooesophageal reflux disease
3%Rash
3%Oropharyngeal pain
2%Upper respiratory tract infection
2%Vitamin d deficiency
2%Glomerular filtration rate decreased
2%Acute myeloid leukaemia
1%Haemorrhoids
1%Glaucoma
1%Subileus
1%Angina unstable
1%Mesenteric vein thrombosis
1%Sudden death
1%Non-hodgkin's lymphoma
1%Burkitt's lymphoma
1%Drug hypersensitivity
1%Transient ischaemic attack
1%Papillary thyroid cancer
1%Myelodysplastic syndrome
1%Oral candidiasis
1%Deep vein thrombosis
1%Abdominal hernia
1%Mucosal inflammation
1%Sepsis
1%Procedural pain
1%Lower respiratory tract infection
0%Taste disorder
0%Biliary colic
0%Cardiac failure
0%Foot fracture
0%Myocardial infarction
0%Colonic abscess
0%Pleural effusion
0%Gastroenteritis viral
0%Atrial fibrillation
0%Dysarthria
0%Vertigo
0%Contrast media allergy
0%Small intestinal obstruction
0%Metastases to central nervous system
0%Respiratory tract infection
0%Muscle spasms
0%Oedema peripheral
0%Femoral neck fracture
0%Personality change
0%Irritability
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the gBRCAm ARM group. Side effects include: Nausea with 56%, Fatigue with 44%, Anaemia with 44%, Vomiting with 28%, Diarrhoea with 17%.

Trial Design

1 Treatment Group

OLAPARIB
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

OLAPARIB
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~2060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: defined as the time from start of treatment to the date of death due to any cause up to 5 years
Closest Location: Dana Farber Cancer Institute · Boston, MA
Photo of dana farber cancer institute 1Photo of dana farber cancer institute 2Photo of dana farber cancer institute 3
2004First Recorded Clinical Trial
3 TrialsResearching Cutaneous Melanoma
542 CompletedClinical Trials

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,935 Previous Clinical Trials
91,865,501 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,008 Previous Clinical Trials
393,031 Total Patients Enrolled
Tamara Sussman, MDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Participants must have measurable disease as defined by RECIST 1.1 criteria.
You have an ECOG performance status of ≤1.
Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days.
Children and adolescents are not eligible for this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.