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Dose-escalation Study of Lupartumab Amadotin (BAY1129980)

NCT02134197 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-12-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate:

* The side effects of BAY1129980 when given every 21 days different dose levels.
* Determine the dose level of BAY1129980 that should be tested in future clinical research studies.
* Measure how much BAY1129980 is in the blood at specific times after administration.
* If treatment with BAY1129980 shows any effect on reducing the tumor growth.
* If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not.
* If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).

Conditions

  • Neoplasms

Interventions

DRUG

Lupartumab Amadotin (BAY1129980)

Starting dose is 0.15mg/kg intravenous (I.V.) administration every 21 days.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-22
Primary Completion
2018-08-30
Completion
2018-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02134197 on ClinicalTrials.gov