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Completed

NCT Number: NCT00782574

Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2281

Drug

Tablets Oral BID

Other names: Olaparib; Lynparza

Cisplatin

Drug

IV every 3 weeks

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2023
First posted
Oct 31, 2008
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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