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PARP Inhibitor

Olaparib for Advanced Cancer

Phase 2

Waitlist Available

Led By Patricia M LoRusso

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance estimated using the actual body weight and Cockcroft-Gault equation of >= 51 mL/min

Subjects must be diagnosed with a glioma, cholangiocarcinoma or other solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteins; patients must have IDH1 or IDH2 mutation which must be detected in a clinical accredited laboratory using a Food and Drug Administration (FDA)-approved molecular test or a validated deoxyribonucleic acid (DNA)-based assay conducted in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; only specific mutations that lead to a neomorphic phenotype will be eligible for enrollment, and include IDH1: R132V, R132G, R132S, R132L, R132C and R132H; IDH2: R140W, R140L, R140Q, R172W, R172G, R172S, R172M, R172K

Must not have

Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

Adults with advanced glioma, cholangiocarcinoma, or solid tumors that have IDH1/IDH2 mutations and are treatment-resistant can join. They must meet certain health criteria like blood cell counts, organ function tests, agree to use contraception if applicable, and be willing to undergo biopsies. Those with recent major surgery, uncontrolled medical issues, HIV/hepatitis or a history of other cancers may not qualify.

What is being tested?

The trial is testing Olaparib's effectiveness on patients whose cancer has spread and doesn't respond to standard treatments. It involves taking the drug orally and monitoring its impact through various assessments including biopsies and imaging techniques like CT scans and MRIs.

What are the potential side effects?

Olaparib could potentially cause side effects such as nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Some might experience changes in taste or mild skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are functioning well enough, based on a specific test.

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My tumor has an IDH1 or IDH2 mutation and has not responded to standard treatments.

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My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.

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My MRI shows my brain tumor is growing.

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I am mostly self-sufficient and can carry out daily activities.

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I have never taken the study drug or any PARP inhibitors before.

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My cancer's progress can be measured by specific medical criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I do not have any serious, uncontrolled health issues or infections.

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I have active hepatitis B or C.

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I have had a bone marrow or double cord blood transplant.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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I have never been treated with a PARP inhibitor like olaparib.

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My heart's electrical activity or my family has a history of abnormal rhythms.

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I am not taking any strong or moderate drugs that affect liver enzymes.

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I have brain metastases that are causing symptoms and are not under control.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

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I am not taking strong or moderate CYP3A inhibitor medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Incidence of adverse events

Progression-free survival

Other study objectives

Plasma

2HG plasma magnetic resonance spectroscopy levels

Dysgeusia

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

Nausea

47%

Fatigue

38%

Diarrhoea

29%

Abdominal pain

29%

Anaemia

28%

Constipation

27%

Decreased appetite

27%

Back pain

26%

Vomiting

21%

Arthralgia

19%

Pyrexia

18%

Asthenia

13%

Rash

13%

Nasopharyngitis

11%

Alanine aminotransferase increased

11%

Dyspnoea

10%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib)Experimental Treatment5 Interventions

Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and/or MRI, as well as a tumor biopsy and blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160