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The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

A Phase I, Open Label, 2 Part Study to Determine the Pharmacokinetics of Olaparib 300 mg bd Administered as Monotherapy and Olaparib 100 mg bd as Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours

NCT02430311•AstraZeneca

View on ClinicalTrials.gov

Summary

This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2

Detailed Description

Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2 will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle). In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in combination with weekly paclitaxel will also be investigated in Chinese patients.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of fully informed consent
•2. Patient aged ≥ 18 years
•3. Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists
•4. life expectancy of ≥ 12 weeks
•5. Patients for Cohort 2 must be eligible for paclitaxel treatment
•6. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
•7. ECOG performance status ≤ 2
•8. Satisfactory organ and bone marrow function measured within 28 days prior to administration of study treatment including - Haemoglobin ≥ 10.0 g/dL and no blood transfusion in the 4 weeks prior to the first dosing of study drug. - Absolute neutrophil count ≥ 1.5 × 109/L
•9. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on Day 1.
•10. 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.

Exclusion Criteria

•1. Involvement in the planning and/or conduct of the study.
•2. Previous enrolment in the present study.
•3. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
•4. Any previous treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor, including olaparib.
•5. Patients with other malignancy within the last 5 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1, Grade 1 endometrial cancer, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.
•6. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. These include patients with gastric or intestinal cancer or patients with prior surgical procedures such as full or partial gastrectomy.
•7. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study treatment.
•8. Concomitant use of known potent CYP3A4 (Cytochrome P450 3A4) inhibitors.
•9. Patients with any ongoing toxicities (\>CTCAE (Common Terminology Criteria for Adverse Events) grade 2), with the exception of alopecia, caused by previous cancer therapy.
•10. Resting ECG with QTc (Heart Rate Corrected QT interval) \> 470msec or family history of long QT syndrome.
+10 more criteria

Locations (3)

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Hangzhou, China

Key Dates

Start Date

June 10, 2015

Primary Completion Date

July 27, 2016

Completion Date

April 28, 2017

Last Updated

July 31, 2019

Enrollment

ACTUAL participants

Conditions

Advanced Solid Tumours

Interventions

Olaparib

DRUG

Paclitaxel

DRUG

Olaparib

DRUG

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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: July 31, 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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The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

Inclusion Criteria

Exclusion Criteria

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