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Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Advanced Solid Tumors

Interventions: AZD2281, Cisplatin

Countries: United States, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Boston, Massachusetts, United States
Boston, Massachusetts, United States
Barcelona, Spain