check_circleStudy Completed
Neoplasms
Bayer Identifier:
12871
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
BothAge
18 - N/ATrial summary
Enrollment Goal
57Trial Dates
November 2009 - February 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 yearsenhanced_encryptionYesSafety Issue:
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 yearsenhanced_encryptionyesSafety Issue:
- Evaluate for early signs of efficacy in expansion cohortsdate_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1