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To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer

NCT02093351•AstraZeneca

View on ClinicalTrials.gov

Summary

This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of written informed consent prior to any study specific procedures
•2. Male or female aged ≥18 years
•3. Histological or cytological confirmation of any malignant solid tumour in an advanced or metastatic setting who meet one of the criteria below:
•* Patients should be resistant or refractory to standard treatment if such treatment exists OR
•* Patients for which no suitable effective standard therapy exists OR
•* Patients with advanced breast cancer for whom anastrozole, letrozole or tamoxifen are indicated may also enter the study (postmenopausal breast cancer patients will be eligible for any of the cohorts; however, premenopausal breast cancer patients will be eligible for the tamoxifen cohort only).
•4. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
•* Haemoglobin (Hb) ≥10.0 g/dL with no blood transfusions in the past 28 days
•* Absolute neutrophil count (ANC) ≥1.5 x 109/L
•* Platelet count ≥100 x 109/L
+14 more criteria

Exclusion Criteria

•1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, its agents, and/or staff at the study site)
•2. Previous enrolment in the present study
•3. Exposure to an investigational product (IP) (including PARP inhibitor) within 30 days or 5 half lives (whichever is the longer) prior to enrolment
•4. Prior chemotherapy within 3 weeks of study entry
•5. Prior radiotherapy within 2 weeks of study entry
•6. If prior endocrine treatment is given, adequate washout period is required: at least 2 weeks for anastrozole, at least 4 weeks for letrozole and at least 10 weeks for tamoxifen
•7. Resting ECG with QTc \>470 msec detected on 2 or more time points within a 24 hour period, or family history of long QT syndrome. If ECG demonstrates QTc \>470 msec, patient will be eligible only if repeat ECG demonstrates QTc \<470 msec.
•8. Patients who are receiving inhibitors or inducers of CYP3A4 unless washed out prior to start of study treatment.
•9. Persistent toxicities (Common Toxicity Criteria for Adverse Events \[CTCAE\] grade ≥2) caused by previous cancer therapy, excluding alopecia and/or CTCAE grade 2 peripheral neuropathy
•10. Patients with myelodysplastic syndrome/acute myeloid leukaemia
+7 more criteria

Locations (14)

Research Site

Brussels, Belgium

Research Site

Edegem, Belgium

Research Site

Ghent, Belgium

Research Site

Leuven, Belgium

Research Site

Liège, Belgium

Research Site

Wilrijk, Belgium

Research Site

Herlev, Denmark

Research Site

Bordeaux, France

Research Site

Amsterdam, Netherlands

Research Site

Utrecht, Netherlands

Key Dates

Start Date

September 1, 2014

Primary Completion Date

April 30, 2015

Completion Date

April 29, 2019

Last Updated

October 2, 2019

Enrollment

ACTUAL participants

Conditions

Solid Tumours

Interventions

Olaparib

DRUG

Tamoxifen

DRUG

Anastrozole

DRUG

Letrozole

DRUG

Pharmacokinetic sampling

PROCEDURE

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Inclusion Criteria

Exclusion Criteria

Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

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