CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Cisplatin +2 moredrug
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.

Search/NCT02631590
NCT02631590Phase 2Completed
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Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 16, 2015·Updated Aug 4, 2021

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Gemcitabine, and 1 other intervention for Biliary Carcinoma and 3 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Carcinoma, Gall Bladder Carcinoma, Cholangiocarcinoma, Gastrointestinal Tumor
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartJul 5, 2016
Primary CompletionOct 25, 2019
Study CompletionMar 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.5 years ago

Interventions

Cisplatindrug

Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.

Gemcitabinedrug

Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.

Copanlisibdrug

Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.