Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/14/2019
Start Date:November 12, 2008
End Date:December 31, 2019

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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

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.


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
We found this trial at
2
sites
?
mi
from
Barcelona,
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?
mi
from
Boston, MA
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