Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)
Verified date | June 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.
Status | Completed |
Enrollment | 4 |
Est. completion date | May 2011 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Newly diagnosed patient. - Provision of written informed consent. - De Novo (primary) or Secondary AML. - Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons. Exclusion Criteria: - Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL). - Patients with blast crisis of chronic myeloid leukaemia. - Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia). |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Research Site | Le Chesnay Cedex | |
France | Research Site | Villejuif Cedex | |
United States | Research Site | Cleveland | Ohio |
United States | Research Site | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis | Information on these will be collected from the time of informed consent is signed, throughout the study. | No | |
Secondary | Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC. | During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10. | No |
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