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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: AZD2281 (Drug)
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.
Intervention: Cisplatin (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).(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.(Assessed at screening, visit 9, and at end of every 2 cycles)