Advanced Solid Malignancies Clinical Trial
Official title:
A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies
Verified date | August 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 74 Years |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists. Exclusion Criteria: - Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Research Site | Tokyo |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to determine the safety and tolerability of AZD2281. | assessed after each visit | No | |
Secondary | The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. | assessed after each visit | No |
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