Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)

Group Type EXPERIMENTAL

AZD1152

Intervention Type DRUG

Variable dose via a 7-day continuous infusion

LDAC (low dose cytosine arabinoside)

Intervention Type DRUG

20 mg subcutaneous injection given twice daily

Interventions

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AZD1152

Variable dose via a 7-day continuous infusion

Intervention Type DRUG

LDAC (low dose cytosine arabinoside)

20 mg subcutaneous injection given twice daily

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No