A Multi-centre, Two-stage, Open Label Phase II Study to Assess the Efficacy and Safety of APO866 in the Treatment of Patients With Advanced Melanoma.
Sponsor study identifier
interventional
25
4 countries
6
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
March 2009
Actual (reported)This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth inhibition in cultures of human melanoma cells as well as in animal models with subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated in a phase I study that treated 24 patients with advanced cancer. In that study one of the two patients with advanced melanoma had a stable disease for 5 months with size reduction of some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
February 6, 2007
Actual (reported)February 7, 2007
Actual (reported)February 2008
Actual (reported)March 2009
Actual (reported)To determine the tumor response rate (according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria) as the proportion of eligible patients with stage IV cutaneous melanoma or stage III not amenable to surgery.
Week 16
Safety and tolerability
Week 16 and 12 months follow-up
Time to response
Week 16
Duration of response
Week 16
Progression free survival
12 months
Overall survival
12 months
The treatment period consists of 3 consecutive 28 day cycles. Each cycle starts with a 4 day continuous infusion of the study medication followed by a 24 day break
APO866 is administered as 0.126 mg/m²/hr IV every 4 weeks for 4 consecutive days (96 hours) for a total of 3 cycles
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Dermatology, Medical University Graz
Graz, 8036, Austria
Department of Dermatology, Hopital Henri Modor
Créteil, 94010, France
Department of Dermatologie, Hotel Dieu
Nantes, 44093, France
Department of Dermatology, Charité University Hospital Berlin
Berlin, 10117, Germany
University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University
Mannheim, 68167, Germany
Department of Dermatology, University Hospital of Zürich
Zurich, 8091, Switzerland
Uwe Trefzer, MD PhD
Department of Dermatology, Charité University Hospital, Schumannstrasse 20-21, 10117 Berlin, Germany
25 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2007
First Posted
February 7, 2007
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Contact the study team to confirm eligibility.
Primary Completion
February 2008
Actual (reported)Study Completion
March 2009
Actual (reported)Last Updated
September 29, 2015
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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