Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.

Completed · Phase 2 · Has a placebo group

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.

Key facts

Study ID: NCT01972217
Run by: AstraZeneca
People needed: 158
Starts: 2014-04-01
Expected to finish: 2023-08-24
Last updated by the study team: 2023-11-14

Who can join

Age: 18 and older, up to 130. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated written informed consent prior to any study specific procedures.
Male aged 18 years and older.
Histologically or cytologically proven diagnosis of prostate cancer.
Candidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.
Patients must have a life expectancy ≥12 weeks.
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.
Patients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.
For the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.
Provide informed consent for the pharmacogenetic sampling and analyses.

You may not qualify if…

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, its agents and/or staff at the study site).
Previous treatment in the present study.
Treatment with any of the following:
Previous exposure to any 2nd generation anti-hormonal including abiraterone and enzalutamide
More than 2 prior courses of chemotherapy for metastatic prostate cancer
Previous use of immunotherapy or radium-223 for the treatment of metastatic prostate cancer
Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment;
Any previous exposure to a CYP17 (17α-hydroxylase/C17,20-lyase) inhibitor;
Substrates of CYP2D6 with a narrow therapeutic index (eg, thioridazine);
Potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort).
Any previous treatment with a PARP inhibitor, including olaparib.
With the exception of alopecia or toxicities related to the use of gonadotropinreleasing hormone agonists, any unresolved toxicities from prior therapy greater than CTCAE Grade 2 at the time of starting study treatment.
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Any of the following cardiac criteria:
Mean resting QTc >470 msec obtained from 3 ECGs
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval.
Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
Absolute neutrophil count (ANC) <1.5 x 109/L
Platelet count <100 x 109/L
Haemoglobin (Hb) <100 g/L
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or >5 x ULN in the presence of liver metastases
Total bilirubin >1.5 x ULN if no liver metastases or >3 x ULN in the presence of liver metastases (except in the case of Gilbert's disease)

Where it is running

Research Site — San Diego, California, United States
Research Site — Lake Success, New York, United States
Research Site — Edegem, Belgium
Research Site — Liège, Belgium
Research Site — Wilrijk, Belgium
Research Site — London, Ontario, Canada
Research Site — Greenfield Park, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Brno, Czechia
Research Site — Brno, Czechia
Research Site — Liberec, Czechia
Research Site — Angers, France
Research Site — Dijon, France
Research Site — Lyon, France
Research Site — Lecce, Italy
Research Site — Mirano, Italy
Research Site — Naples, Italy
Research Site — Parma, Italy
Research Site — Pisa, Italy
Research Site — Arnhem, Netherlands
Research Site — Maastricht, Netherlands
Research Site — Nijmegen, Netherlands
Research Site — Gdansk, Poland
Research Site — Warsaw, Poland
Research Site — Ivanovo, Russia

Full record on ClinicalTrials.gov

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