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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: November 4, 2014
Last verified: November 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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:


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 ]

Enrollment: 59
Study Start Date: November 2008
Estimated Study Completion Date: December 2015
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
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 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

Additional 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: November 4, 2014
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
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014