Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2012

Interventions

  • Drug: AZD2281
    • Tablets Oral BID
  • Drug: Cisplatin
    • IV every 3 weeks

Arms, Groups and Cohorts

  • Experimental: 1
    • Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jane Robertson, BSc, MBCHB, MD, Study Director, AstraZeneca
    • Judy E Garber, Principal Investigator, Dana-Farber Cancer Institute
    • J Ballmana Gelpi, Principal Investigator, Vall d’Hebron

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