Olaparib for Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cancer+8 MoreOlaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well olaparib works in treating patients with certain types of cancer that have spread and usually cannot be controlled with treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Cancer
  • Low Grade Glioma
  • Grade III Glioma
  • Recurrent Malignant Solid Tumor
  • Brain Tumor
  • Glioblastoma
  • Grade 3 Glioma
  • Recurrent Cholangiocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 1 year

Year 1
Dysgeusia
Co-occurring alterations detected via mass cytometry (cyTOF), ribonucleic acid (RNA) sequencing and/or deoxyribonucleic acid (DNA) sequencing
Baseline up to post-treatment
Magnetic Resonance Spectroscopy
Year 1
Progression-free survival
Up to 1 year
Plasma
Incidence of adverse events
Up to completion of course 8
Overall response rate

Trial Safety

Safety Progress

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

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%Back pain
7%Alopecia
7%Neutropenia
7%Abdominal pain upper
7%Dyspnoea
7%Insomnia
5%Anxiety
5%Respiratory tract infection
5%Nasopharyngitis
5%Headache
5%Depression
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%Neutrophil count decreased
4%White blood cell 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%Platelet count decreased
2%Muscle spasms
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

145 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Treatment (olaparib)Experimental Group · 5 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Olaparib · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~670
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Phase 3
~1150
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,100 Previous Clinical Trials
41,145,587 Total Patients Enrolled
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
4 Previous Clinical Trials
147 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be able to understand the nature of this trial and provide written informed consent, prior to any study specific procedures; patients with Impaired Decision Making Capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) may be considered eligible for this study at the treating physician's discretion, provided that the physician is reasonably sure that the possible risks and benefits of the study are clear and that the patient will take the drug as prescribed.
You are willing to undergo extra blood sampling for correlative studies.
Subjects with extracranial disease must have evaluable disease by RECIST v1.1; subjects affected by glioma must have evaluable disease by RANO criteria.
You must have an enhancing component of disease, as evaluated on pre-treatment magnetic resonance imaging (MRI).
The radiation dose is greater than the threshold dose.\n
You have unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas