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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

AZD1152 1200 mg, iv, 7 day infusion monotherapy

LDAC 20 mg, sc, bd, 10 days (400mg per cycle)

The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

Study to investigate the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC)in acute myeloid leukaemia (AML) patients

Research Site

A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged ≥ 60 with newly diagnosed acute myeloid leukaemia (AML)

Proportion of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)

Duration of Response was measured from the Response Start date until evidence of patient relapse  or death.

Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.

TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)

Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.

TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu

The score is derived from the sum of the 17 items of the FACT-Leu and the change from baseline to each cycle is derived

Arms	Assigned Interventions
Experimental: AZD1152 1200 mg AZD1152 1200 mg, iv, 7 day infusion monotherapy	Drug: AZD1152 1200 mg, iv, 7 day infusion
Active Comparator: LDAC 20 mg LDAC 20 mg, sc, bd, 10 days (400mg per cycle)	Drug: LDAC 20 mg, sc, bd, 10 days

Study to investigate the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC)in acute myeloid leukaemia (AML) patients - SPARK-AML1

Official Title

Medical condition

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Healthy volunteers

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Study design

Verification:

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Documents available

Cancer Study Locator (US and CA only)

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=279&filename=CSR-D1531C00009.pdf

CSR-D1531C00009.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator