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A Phase I Dose Finding Study of APO010 in Patients With Solid Tumors

NCT00437736 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-09-17

No results posted yet for this study

Summary

Two-centre, open label, uncontrolled, dose-finding phase I study, to determine the safety and tolerability of APO010 administered by intravenous bolus injection once per week. It will be the first time this agent will be administered to humans. At lower dose levels, the first cycle duration is 7 weeks. In subsequent cycles, APO010 is administered as 4 weekly doses followed by a two-week drug rest, cycle duration is 6 weeks. Based on preclinical studies of APO010 may cause liver toxicity and a drop in platelets, that recover within 5 days. The main aim of the study is to identify the recommended dose of APO010 for future clinical studies of APO010.

Conditions

Interventions

DRUG

APO010

APO010 starting at 2.5 µg/m² IV on D1, D15, D22 and D29 followed by a two-week drug rest.

Sponsors & Collaborators

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

  • Cristiana Sessa, Prof, MD · Oncology Institute of Southern Switzerland, Bellinzona Hospital, 6500 Bellinzona, Switzerland

Study Design

Allocation
NA
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
2008-11-30
Completion
2009-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00437736 on ClinicalTrials.gov