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A Long-Term Study of Rovalpituzumab Tesirine

NCT03543358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-01-05

Study results available
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Summary

The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.

Conditions

Interventions

DRUG

rovalpituzumab tesirine

Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles

DRUG

rovalpituzumab tesirine

Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2019-11-26
Completion
2019-11-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03543358 on ClinicalTrials.gov