Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Cisplatin; Drug: AZD2281

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782574

D0810C00021

2008-000062-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: AZD2281