Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients | NCT00782574 | Trialant

Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients | NCT00782574 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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.	Drug: AZD2281 Drug: Cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		Weekly visits for routine monitoring visits

Secondary Outcomes

Measure	Description	Time Frame
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.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Jane Robertson, BSc, MBCHB, MD	AstraZeneca	Study Director
Judy E Garber	Dana-Farber Cancer Institute	Principal Investigator
J Ballmana Gelpi	Vall d'Hebron	Principal Investigator

Intervention Browse Module