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Clinical Trial
. 2013 Jul 15;119(14):2611-9.
doi: 10.1002/cncr.28113. Epub 2013 Apr 19.

Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With Acute Myeloid Leukemia

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Free PMC article
Clinical Trial

Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With Acute Myeloid Leukemia

Hagop M Kantarjian et al. Cancer. .
Free PMC article

Abstract

Background: In this phase 2 study, the authors evaluated the efficacy, safety, and tolerability of the Aurora B kinase inhibitor barasertib compared with low-dose cytosine arabinoside (LDAC) in patients aged ≥ 60 years with acute myeloid leukemia (AML).

Methods: Patients were randomized 2:1 to receive either open-label barasertib 1200 mg (as a 7-day intravenous infusion) or LDAC 20 mg (subcutaneously twice daily for 10 days) in 28-day cycles. The primary endpoint was the objective complete response rate (OCRR) (complete responses [CR] plus confirmed CRs with incomplete recovery of neutrophils or platelets [CRi] according to Cheson criteria [also requiring reconfirmation of CRi ≥21 days after the first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety.

Results: In total, 74 patients (barasertib, n = 48; LDAC, n = 26) completed ≥1 cycle of treatment. A significant improvement in the OCRR was observed with barasertib (35.4% vs 11.5%; difference, 23.9%; 95% confidence interval, 2.7%-39.9%; P < .05). Although the study was not formally sized to compare OS data, the median OS with barasertib was 8.2 months versus 4.5 months with LDAC (hazard ratio, 0.88; 95% confidence interval, 0.49-1.58; P = .663). Stomatitis and febrile neutropenia were the most common adverse events with barasertib versus LDAC (71% vs 15% and 67% vs 19%, respectively).

Conclusions: Barasertib produced a significant improvement in the OCRR versus LDAC and had a more toxic but manageable safety profile, consistent with previous studies.

Keywords: AZD1152; acute myeloid leukemia; barasertib; low-dose cytosine arabinoside.

Conflict of interest statement

Conflict of interest disclosure: HK has received research grants from AstraZeneca; GM is a Consultant for Novartis, BMS, Pfizer and Roche, and on speaker bureaus for Novartis, BMS and Pfizer; NS is an AZ employee; KO, LP and PS are AZ employees and shareholders. The remaining authors declare no competing financial interests.

Figures

Figure 1
Figure 1. Duration of response
Figure 2
Figure 2. Kaplan–Meier curves of overall survival for modified intent-to-treat population (A) and by cytogenetic risk group (B)
Figure 2
Figure 2. Kaplan–Meier curves of overall survival for modified intent-to-treat population (A) and by cytogenetic risk group (B)
Figure 3
Figure 3. Number of treatment cycles received

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