NCT01953536

Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)

A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects With Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Subject Selection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Endocyte · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC). The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.

Detailed description

During the screening stage, participants will be required to have a diagnostic computed tomography (CT) scan with etarfolatide (EC20) to identify target lesions and determine eligibility for treatment. After successful screening, during the treatment stage, participants will receive study drug (vintafolide, vintafolide + paclitaxel, or paclitaxel) for approximately four 28-day cycles.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Vintafolide 2.5 mg	During treatment, participants receive IV vintafolide 2.5 mg.
DRUG	Paclitaxel 80 mg/m^2	During treatment, participants receive IV paclitaxel 80 mg/m\^2.
DRUG	Etarfolatide	During screening and prior to screening CT scan, participants receive an IV injection of 0.1 mg etarfolatide radiolabeled with 20 to 25 milliCuries of technetium-99m.
DRUG	Folic acid	During screening and prior to etarfolatide injection and screening CT scan, participants receive an IV injection of 0.5 mg folic acid.
DRUG	Premedication for Paclitaxel	During treatment, participants receive dexamethasone 20 mg orally 12 to 6 hours prior to paclitaxel; OR promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel; OR cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-10-01
• Last updated: 2014-12-19