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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