Text Size

Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00782574
First received: October 29, 2008
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: February 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782574

Locations
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Spain
Research Site
Barcelona, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00782574     History of Changes
Other Study ID Numbers: D0810C00021
Study First Received: October 29, 2008
Last Updated: December 14, 2012
Health Authority: Spain: Ministry of Health
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced solid tumours
Poly(ADP ribose) polymerases
homologous deficiency
BRCA1

Additional relevant MeSH terms:
Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013