Acute Myeloid Leukaemia Clinical Trial
Official title:
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.
| Verified date | September 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
| Study type | Interventional |
The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | August 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission - Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments. Exclusion Criteria: - Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug - Participation in any other trial with an investigational product within the previous 30 days. - Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Chuo | Tokyo |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Isehara | Kanagawa |
| Japan | Research Site | Maebashi-city | Gunma |
| Japan | Research Site | Nagoya | Aichi |
| Japan | Research Site | Yokohama | Kanagawa |
| Japan | Research Site | Yoshida-gun | Fukui |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis | assessed at each visit | ||
| Secondary | To examine the pharmacokinetics of AZD1152 | assessed after dose administration |
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