Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

April 30, 2012

Study Completion Date

July 31, 2012

Conditions
Breast CancerBreast TumorsNeoplasms, BreastCancer of the BreastHuman Mammary Carcinoma
Interventions
DRUG

Pralatrexate Injection

"Intravenous (IV) push administration over 3-5 minutes.~Initial dose: 190 mg/m2~Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.~Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met."

DIETARY_SUPPLEMENT

Vitamin B12

"1 mg intramuscular injection~Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate."

DIETARY_SUPPLEMENT

Folic Acid

"1.0-1.25 mg orally~Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate."

Trial Locations (14)

4032

University of Debrecen Medical and Health Science Center, Debrecen

13273

Institut Paoli Calmettes, Marseille

21079

Centre Georges François Leclerc, Dijon

34298

Centre Lutte Contre le Cancer Val d'Aurelle (CRLC), Montpellier

38120

The West Clinic, Memphis

51056

Institut Jean-Godinot, Reims

54511

Centre Régional de Lutte Contre le Cancer Alexis Vautrin, Vandœuvre-lès-Nancy

69373

Centre Léon Bérard, Lyon

97213

Providence Cancer Center, Portland

775 20

Fakultní nemocnice Olomouc, Olomouc

532 03

Multiscan, s.r.o., Pardubice

100 34

Fakultní nemocnice Královské Vinohrady - FNKV, Prague

H-1082

Semmelweis University Budapest, Budapest

H-1145

National Health Centre of Hungary, Budapest

Sponsors
All Listed Sponsors
lead

Acrotech Biopharma Inc.

INDUSTRY