This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 29, 2008
Last updated: August 1, 2017
Last verified: July 2017
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.

Condition Intervention Phase
Advanced Solid Tumors Drug: AZD2281 Drug: Cisplatin Phase 1

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 56
Actual Study Start Date: November 12, 2008
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: February 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD2281 + Cisplatin combination therapy
Drug: AZD2281
Capsule Oral bid
Other Name: Olaparib
Drug: Cisplatin
IV every 3 weeks


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00782574

United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
Research Site
Boston, Massachusetts, United States, 02115
Research Site
Boston, Massachusetts, United States, 02215
Research Site
Barcelona, Spain, 08035
Sponsors and Collaborators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Judy E Garber Dana-Farber Cancer Institute
Principal Investigator: J Ballmana Gelpi Vall d'Hebron
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00782574     History of Changes
Other Study ID Numbers: D0810C00021
Study First Received: October 29, 2008
Last Updated: August 1, 2017

Keywords provided by AstraZeneca:
Advanced solid tumours
Poly(ADP ribose) polymerases
homologous deficiency

Additional relevant MeSH terms:
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017