Olaparib for Leukemia, Myeloid

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Leukemia, Myeloid+13 More
Olaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well olaparib works in treating patients with AML or MDS that has relapsed or is refractory. Olaparib may stop cancer cell growth by blocking enzymes needed for cell growth.

Eligible Conditions
  • Leukemia, Myeloid
  • Leukemia, Myelocytic, Acute
  • MYELODYSPLASTIC SYNDROME
  • Recurrent Myelodysplastic Syndrome
  • Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 12 months

Month 12
Overall survival (OS)
Month 12
Progression-free survival (PFS)
Month 12
Duration of response (DOR)
Up to 12 months
Change in 2-hydroxyglutarate (2HG) levels
Incidence of adverse events
Minimal residual disease (MRD) assessment
Mutant allele frequency
Overall response rate (ORR)
Up to 6 cycles
Cumulative ORR

Trial Safety

Safety Progress

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

Side Effects for

sBRCAm
51%Nausea
40%Fatigue
35%Anaemia
25%Vomiting
22%Abdominal pain
20%Asthenia
16%Diarrhoea
15%Constipation
15%Dyspepsia
13%Decreased appetite
11%Oedema peripheral
11%Urinary tract infection
11%Thrombocytopenia
11%Upper respiratory tract infection
11%Arthralgia
9%Musculoskeletal pain
9%Cough
7%Alopecia
7%Back pain
7%Neutropenia
7%Abdominal pain upper
7%Dyspnoea
7%Insomnia
5%Depression
5%Nasopharyngitis
5%Respiratory tract infection
5%Headache
5%Anxiety
5%Blood creatinine increased
5%Rash
5%Glomerular filtration rate decreased
5%Mucosal inflammation
5%Vitamin d deficiency
5%Dysgeusia
5%Pruritus
5%Hypertension
4%White blood cell count decreased
4%Neutrophil count decreased
4%Pain in extremity
4%Leukopenia
4%Dizziness
4%Abdominal distension
4%Influenza like illness
4%Hypomagnesaemia
4%Pyrexia
4%Peripheral swelling
2%Muscle spasms
2%Platelet count decreased
2%Biliary colic
2%Atrial fibrillation
2%Cardiac failure
2%Deep vein thrombosis
2%Small intestinal obstruction
2%Metastases to central nervous system
2%Bronchitis
2%Alanine aminotransferase increased
2%Myalgia
2%Oropharyngeal pain
2%Dysarthria
2%Contrast media allergy
2%Femoral neck fracture
2%Colonic abscess
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the sBRCAm ARM group. Side effects include: Nausea with 51%, Fatigue with 40%, Anaemia with 35%, Vomiting with 25%, Abdominal pain with 22%.

Trial Design

1 Treatment Group

Treatment (olaparib)
1 of 1

Experimental Treatment

94 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Treatment (olaparib)
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,005 Previous Clinical Trials
41,301,833 Total Patients Enrolled
569 Trials studying Leukemia, Myeloid
79,525 Patients Enrolled for Leukemia, Myeloid
Thomas PrebetPrincipal InvestigatorYale University Cancer Center LAO
Rory M ShallisPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The text is about the diagnosis of MDS or AML.AML may be de novo, or following a prior hematologic disorder, including MDS or Philadelphia chromosome-negative myeloproliferative neoplasm, and/or therapy-related.
This study is evaluating whether an experimental HIV vaccine may help prevent HIV infection in people who have already been infected.
You have chronic hepatitis B virus (HBV) infection.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured
Patients with MDS should have at least a MDS-excess blasts (EB)1 at the inclusion and have a revised International Prognostic Symptom Score risk stratification of intermediate, high, or very high risk.
People who are at least 18 years old can participate in this study

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 17th, 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.