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Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer

NCT03023722 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-10-28

Study results available
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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)

Conditions

Interventions

DRUG

anetumab ravtansine

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Stacey Stein, MD · Yale Cancer Center, Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2019-08-06
Completion
2019-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03023722 on ClinicalTrials.gov