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)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 30, 2014

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Breast Neoplasms
Interventions
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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endocyte

INDUSTRY

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) | Biotech Hunter | Biotech Hunter