Clinical Trial: A Phase I, Dose-escalation Study of AS703569 Given Orally to Subjects With Haematological Malignancies

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase I, Dose-escalation Study of AS703569 Given Orally to Subjects With Haematological Malignancies

Brief Summary: EMD Serono decided to terminate enrollment based on a review of the available clinical data and low probability of completing the trial based on the observed recruitment rate. Subjects already enrolled in the study continued participation in the study, consistent with the protocol, to study completion.

Detailed Summary: The goal of this research study is to investigate for the first time the safety and tolerability of a new drug (AS703569), called an aurora kinase inhibitor, being tested to treat blood cancers in patients with different blood cancers. The research study will also assess how the body breaks down AS703569 and what changes occur in the blood after oral doses of AS703569. It will also look to see if there is any improvement in your blood cancer. The use of AS703569 in this study is experimental.
Sponsor: EMD Serono

Current Primary Outcome:

  • Dose-Limiting Toxicity (DLT) [ Time Frame: 21 days or 1 cycle ]
    Dose-escalation part - The number of subjects experiencing at least a Dose-Limiting Toxicity (DLT), judged to be related to the study medication, evaluated over the first cycle only for each dose level and regimen, independently.
  • Preliminary anti-tumour activity [ Time Frame: 42 days or 2 cycles ]
    Cohort expansion part - Preliminary anti-tumour activity in four selected cohorts of haematological malignancies as assessed every two cycles


Original Primary Outcome: Same as current

Current Secondary Outcome: Treatment-emergent adverse events (TEAE) [ Time Frame: minimum 21 days or 1 cycle ]

Dose-escalation and Cohort expansion parts The proportion/number of subjects experiencing treatment-emergent adverse events (TEAE) after the first cycle and during multiple cycles, in each cohort for each of the 2 dose-regimens.


Original Secondary Outcome: Same as current

Information By: EMD Serono

Dates:
Date Received: March 2, 2010
Date Started: December 2006
Date Completion:
Last Updated: October 21, 2013
Last Verified: October 2013