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A Phase I/II Study to Assess the Safety and Tolerability of APO866 for the Treatment of Refractory B-CLL

NCT00435084 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-09-23

No results posted yet for this study

Summary

This phase I/II study is designed to determine the safety and tolerability of APO866 for the treatment of refractory B-CLL not amenable to aHSCT. APO866 has shown to induce growth inhibition in cultures of a wide variety of human hematological malignant cells as well as in models with subcutaneously implanted human tumors. APO866 was considered to be safe and well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is administered by intravenous infusion continuously for 96 hours and is repeated every 4 weeks. In this study patients will receive only one cycle of treatment and the study endpoints will be evaluated 4 weeks after the start of infusion. Patients will be followed up for 12 weeks for safety.

Conditions

  • B-cell Chronic Lymphocytic Leukemia

Interventions

DRUG

APO866

Sponsors & Collaborators

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

  • Peter Hillmen, MD PhD · Department of Heamatology, D Floor, Brotherton Wing, Leeds General Infirmary, Great George street, Leeds LS1 3EX

  • René Goedkoop, MD · Apoxis SA, 18-20 Avenue de Sévelin, 1004 Lausanne, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-02-29
Completion
2009-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00435084 on ClinicalTrials.gov