check_circleStudy Completed

Neoplasms

BAY80-6946 open label, phase I study in patients with advanced cancer

Trial purpose

The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
57
Trial Dates
November 2009 - February 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Pittsburgh, 15213, United States
Completed
San Antonio, 78229-3307, United States
Completed
Scottsdale, 85258, United States

Primary Outcome

  • Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response.
    date_rangeTime Frame:
    2 years
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    Safety Issue:
    Yes

Secondary Outcome

  • Determine the effects of BAY80-6946 on blood glucose and insulin, and its safety in patients with type I or II diabetes.
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    yes
  • Evaluate for early signs of efficacy in expansion cohorts
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    no

Trial design

An open label Phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics, maximum tolerated dose and biomarker response after intravenous administration of weekly BAY80-6946 to patients with advanced cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1