Olaparib for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fundación Colombiana de Cancerología Clínica Vida ( Site 2902), Medellin, ColombiaSolid TumorsOlaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether adding olaparib to pembrolizumab will help treat patients with solid tumors that have mutations that affect the Homologous Recombination Repair process.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Pembrolizumab Injection [Keytruda]
1
MK-1084
1
Olaparib

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Up to ~3 years

Up to ~3 years
Duration of Response (DOR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations
Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants with Cancer Antigen-125 (CA-125) Level of ≥2 × Upper Limit of Normal (ULN) Among Participants with Ovarian Cancer
CA-125 Antigen
Number of Participants with a Change from Baseline in Prostate-Specific Antigen (PSA) Level of ≥50% Among Participants with Prostate Cancer
Objective Response Rate (ORR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups
Overall Survival (OS) in Additional Biomarker Subpopulations
Overall Survival (OS) in Biomarker Subgroups
Progression-Free Survival (PFS) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations
Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups

Trial Safety

Safety Progress

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

Similar Trials

1
Pembrolizumab Injection [Keytruda]
1
MK-1084
1
Olaparib

Side Effects for

gBRCAm
56%Nausea
44%Fatigue
44%Anaemia
28%Vomiting
17%Diarrhoea
16%Dyspepsia
15%Dizziness
15%Asthenia
14%Neutropenia
13%Headache
13%Arthralgia
13%Abdominal pain
11%Decreased appetite
10%Nasopharyngitis
10%Abdominal pain upper
10%Cough
10%Dyspnoea
9%Dysgeusia
9%Blood creatinine increased
8%Influenza like illness
8%Alanine aminotransferase increased
8%Insomnia
8%Back pain
8%Influenza
8%Alopecia
7%Pyrexia
7%Hypomagnesaemia
7%Abdominal distension
7%Leukopenia
6%Constipation
6%Urinary tract infection
6%Peripheral swelling
6%Thrombocytopenia
6%Bronchitis
6%Neutrophil count decreased
6%Platelet count decreased
6%White blood cell count decreased
5%Pain in extremity
5%Anxiety
5%Musculoskeletal pain
5%Myalgia
5%Depression
5%Pruritus
3%Gastrooesophageal reflux disease
3%Rash
3%Pulmonary embolism
3%Hypertension
3%Abdominal pain lower
3%Oropharyngeal pain
2%Vitamin d deficiency
2%Glomerular filtration rate decreased
2%Acute myeloid leukaemia
2%Upper respiratory tract infection
1%Angina unstable
1%Non-hodgkin's lymphoma
1%Sudden death
1%Oral candidiasis
1%Glaucoma
1%Drug hypersensitivity
1%Deep vein thrombosis
1%Mesenteric vein thrombosis
1%Subileus
1%Abdominal hernia
1%Sepsis
1%Haemorrhoids
1%Mucosal inflammation
1%Lower respiratory tract infection
1%Procedural pain
1%Burkitt's lymphoma
1%Papillary thyroid cancer
1%Transient ischaemic attack
1%Myelodysplastic syndrome
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+Pembrolizumab
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Olaparib+PembrolizumabExperimental Group · 2 Interventions: Olaparib, Pembrolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~3 years

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,732 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,707 Previous Clinical Trials
4,963,906 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,654 Previous Clinical Trials
7,956,856 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Is this research project presently recruiting participants?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this experiment is presently accepting participants, having first been listed in November 2019 and last updated two years later." - Anonymous Online Contributor

Unverified Answer

Are there any precedent investigations into the effects of Olaparib?

"Olaparib was initially explored in 2005 at Research Site. Since then, 314 clinical trials have concluded and 1114 are currently underway; San Francisco is the epicentre for many of these investigations." - Anonymous Online Contributor

Unverified Answer

What is the size of the cohort that is being monitored for this experiment?

"Affirmative. The information published on clinicaltrials.gov suggests that this scientific experiment is currently recruiting for 300 participants across 18 sites, with the first post appearing November 18th 2019 and latest update completed November 29th 2022." - Anonymous Online Contributor

Unverified Answer

Is this pioneering clinical trial a first-time endeavor?

"Since 2005, when the initial research was sponsored by AstraZeneca and included 98 patients, Olaparib has gone on to receive Phase 1 drug approval. Nowadays, there are 1114 clinical studies being conducted across 66 nations in 3058 cities." - Anonymous Online Contributor

Unverified Answer

Are there numerous health care centers trialing this protocol domestically?

"Currently, 18 clinical trial sites are recruiting patients for this medical study. These locations span from San Francisco to Birmingham and Fairfax as well as several other cities. To limit the need for travel, we suggest selecting a site close by when enrolling in the trial." - Anonymous Online Contributor

Unverified Answer

How detrimental is Olaparib for patients?

"Olaparib has been assessed as a 2 on the safety scale, given that Phase 2 only offers limited evidence of its security but no proof of efficacy." - Anonymous Online Contributor

Unverified Answer

In what capacity is Olaparib generally employed?

"Olaparib is commonly utilized to treat inoperable melanoma, as well as high risk of recurrence cases and microsatellite instability conditions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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