---
title: Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)
nct_id: NCT00926731
overall_status: COMPLETED
phase: PHASE1
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Acute Myeloid Leukemia
countries: United States, France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00926731.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00926731"
ct_last_update_post_date: 2011-06-16
last_seen_at: "2026-05-12T06:24:46.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

**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)

**NCT ID:** [NCT00926731](https://clinicaltrials.gov/study/NCT00926731)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 4
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Acute Myeloid Leukemia
- **Start Date:** 2009-06
- **Completion Date:** 2011-05
- **CT.gov Last Update:** 2011-06-16

## Brief Summary

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.

## Eligibility

- **Minimum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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).
```

## Arms

- **1** (EXPERIMENTAL) — AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)

## Interventions

- **AZD1152** (DRUG) — Variable dose via a 7-day continuous infusion
- **LDAC (low dose cytosine arabinoside)** (DRUG) — 20 mg subcutaneous injection given twice daily

## Primary Outcomes

- **Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis** _(time frame: Information on these will be collected from the time of informed consent is signed, throughout the study.)_

## Secondary Outcomes

- **Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.** _(time frame: 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.)_

## Locations (4)

- Research Site, Cleveland, Ohio, United States
- Research Site, Houston, Texas, United States
- Research Site, Le Chesnay, France
- Research Site, Villejuif, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.research site|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.research site|houston|texas|united states` — added _(2026-05-12)_
- `locations.research site|le chesnay||france` — added _(2026-05-12)_
- `locations.research site|villejuif||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00926731.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00926731*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*