Olaparib for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Nedlands, AustraliaSolid TumorsOlaparib - Drug
Eligibility
No minimum age - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety of a drug called olaparib in children and adolescents with solid tumors.

Eligible Conditions
  • Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
BI 1823911
1
PF-07284890
1
Olaparib

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Up to 64 months

28 days
Dose limiting toxicity [DLTs]
Day 29
Apparent total clearance of the drug from plasma at steady state after oral administration [CLss/F]
Area under the curve at 0-8 hours [AUC(0-8)]
Area under the curve at steady state [AUCss]
Area under the curve from zero up to time t [AUC0-t]
Dose normalised area under the curve at steady state [dose normalised AUCss]
Dose normalised maximum plasma concentration at steady state [dose normalised Css,max]
Maximum plasma concentration at steady state [Css,max]
Minimum plasma concentration at steady state [Css, min]
Time to maximum plasma concentration at steady state [tss,max]
Day 30
Safety profile
Up to 64 months
DCR as defined by Investigator-assessed RECIST v1.1, INRC or RANO
DoR as defined by Investigator-assessed RECIST v1.1, INRC or RANO
ORR as defined by Investigator-assessed RECIST v1.1, INRC or RANO

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
BI 1823911
1
PF-07284890
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%Musculoskeletal pain
5%Anxiety
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

4 Treatment Groups

Cohort B: ≥3 to <12 years
1 of 4
Cohort A: ≥12 to <18 years
1 of 4
Cohort C: ≥6 months to <6 years
1 of 4
Signal identification
1 of 4

Experimental Treatment

30 Total Participants · 4 Treatment Groups

Primary Treatment: Olaparib · No Placebo Group · Phase 1

Cohort B: ≥3 to <12 years
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Cohort A: ≥12 to <18 years
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Cohort C: ≥6 months to <6 years
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Signal identification
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 64 months

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,015 Previous Clinical Trials
240,372,828 Total Patients Enrolled
Milenkova TsvetaStudy DirectorAstraZeneca

Eligibility Criteria

Age No minimum age - 18 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You should be able to swallow pills.
References

Frequently Asked Questions

Is this research original or has it already been conducted?

"Olaparib has had a long history of clinical trials, with the first study taking place in 2005. Sponsored by AstraZeneca, this original trial involved 98 patients and led to Phase 1 drug approval. Currently, 59 countries around the world host 188 active studies on Olaparib across 1468 cities." - Anonymous Online Contributor

Unverified Answer

Is there any eligibility criteria preventing me from partaking in this research?

"Individuals aged 0-18, who possess solid tumors are eligible to apply for this trial. There is a maximum of 30 participants that will be accepted in total." - Anonymous Online Contributor

Unverified Answer

How many participants have committed to this research project?

"Affirmative, the data from clinicaltrials.gov states that recruiting is underway for this trial which was initially uploaded on January 14th 2020 and last reviewed November 7th 2022. This research requires 30 subjects to be enrolled across two sites." - Anonymous Online Contributor

Unverified Answer

What are the expected results of this research?

"Over a period of 28 days, the primary observed outcome of this trial will be safety. Secondary outcomes include Area under the Curve at Steady State levels in mcg/mL, as well as Objective Response Rate based on International Neuroblastoma Response Criteria, RECIST and RANO standards." - Anonymous Online Contributor

Unverified Answer

Has Olaparib been granted permission for sale by the Food and Drug Administration?

"There is limited data on the efficacy and safety of Olaparib, which earned it a score of 1." - Anonymous Online Contributor

Unverified Answer

Are there any other research investigations which have employed Olaparib?

"Olaparib was first tested in research labs back in 2005. Presently, there have been 63 clinical trials completed and 188 active studies taking place; many of them located within the province of Quebec, Montreal." - Anonymous Online Contributor

Unverified Answer

What is the principal therapeutic application of Olaparib?

"Olaparib is frequently prescribed for the treatment of advance directives, but it can also be employed to handle malignant neoplasm of ovary, primary peritoneal cancer, and somatic hallucinations." - Anonymous Online Contributor

Unverified Answer

Is the upper age limit for recruitment of this trial below sixty years?

"This clinical trial can only accept minors between 0 and 18 years old. Presently, there are 329 trials for youths and 2573 trails designed for the elderly population." - Anonymous Online Contributor

Unverified Answer

Are any participants being enrolled into this experiment at the moment?

"This research is currently looking for participants; the trial went live on January 14th 2020 and was amended as of November 7th 2022, per clinicaltrials.gov." - 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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