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

NCT02430311 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-07-31

Study results available
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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

Conditions

  • Advanced Solid Tumours

Interventions

DRUG

Olaparib

Tablet-150mg, Oral

DRUG

Paclitaxel

Injection

DRUG

Olaparib

Tablet-100mg, Oral

Sponsors & Collaborators

Principal Investigators

  • Binghe Xu, MD · Cancer Institute and Hospital (CIH), Chinese Academy of Medical Sciences and Peking Union Medical College

  • Jianming Xu, MD · 307 Hospital of Military Medical Sciences

  • Jianzhong Shentu · No.1 Affiliated Hospital of College of Medicine, Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-10
Primary Completion
2016-07-27
Completion
2017-04-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02430311 on ClinicalTrials.gov