CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
anetumab ravtansinedrug
Likely dose
anetumab ravtansine 6.5 mg/kgfrom 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/NCT03023722
NCT03023722Phase 2Completed
CompareCT.gov

An Open-label, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343), an Anti-mesothelin Antibody Drug Conjugate, in Pretreated Mesothelin-expressing Advanced Pancreatic Cancer

Yale University·interventional·Posted Jan 18, 2017·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating anetumab ravtansine for Pancreatic Cancer. Completed, enrolled 18 participants across 3 sites.

Detailed Summary

The primary objective of this study is to: -Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients with advanced pancreatic cancer who stain for mesothelin expression The secondary objectives of this study are to: * Time to Progression (TTP) defined as time from study treatment to RECIST 1.1 progression, or death (others going off study will be censored) * Toxicity in pancreatic cancer patients (at 6.5 mg/kg dose)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 18, 2017
Enrollment StartMay 11, 2017
Primary CompletionAug 6, 2019
Study CompletionDec 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.5 years ago

Interventions

anetumab ravtansinedrug

Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle