At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 enrolled
Drug / intervention
Copanlisib (Aliqopa, BAY80-6946)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Copanlisib (Aliqopa, BAY80-6946) for Neoplasms. Completed, enrolled 57 participants across 3 sites.
Detailed Summary
The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartNov 2009
Primary CompletionFeb 2016
TodayJul 2026
First PostedAug 20, 2009
Enrollment StartNov 19, 2009
Primary CompletionFeb 23, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.9 years ago
Interventions
Copanlisib (Aliqopa, BAY80-6946)drug
BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop.