Overview

This trial is active, not recruiting.

Condition advanced solid tumors
Treatments azd2281, cisplatin
Phase phase 1
Target PARP
Sponsor AstraZeneca
Start date November 2008
End date February 2012
Trial size 59 participants
Trial identifier NCT00782574, D0810C00021

Summary

A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AZD2281 + Cisplatin combination therapy
azd2281 Olaparib
Capsule Oral bid
cisplatin
IV every 3 weeks

Primary Outcomes

Measure
To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.
time frame: Weekly visits for routine monitoring visits

Secondary Outcomes

Measure
To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).
time frame: PK samples taken at visit 2 and 3
To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate.
time frame: Assessed at screening, visit 9, and at end of every 2 cycles

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Life expectancy of at least 12 weeks - Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent - Patients with measurable or non measurable disease according to RECIST Exclusion Criteria: - Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy - Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for >1 week - Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy

Additional Information

Official title A Phase I Open Label, Multi Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours
Principal investigator Judy E Garber
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.