CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
Nab-Paclitaxel and Gemcitabinedrug
Likely dose
Nab-Paclitaxel and Gemcitabine 125 mgfrom 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/NCT02181634
NCT02181634Phase 2Completed
CompareCT.gov

A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma

PrECOG, LLC.·interventional·Posted Jul 4, 2014·Updated Oct 3, 2018

In Brief

A Phase 2 clinical trial evaluating Nab-Paclitaxel and Gemcitabine for Cholangiocarcinoma. Completed, enrolled 74 participants across 25 sites in 2 countries.

Detailed Summary

Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholangiocarcinoma
CountriesAustria, United States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 4, 2014
Enrollment StartDec 9, 2014
Primary CompletionSep 24, 2016
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.0 years ago

Interventions

Nab-Paclitaxel and Gemcitabinedrug

Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes.