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

NCT01118624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-01-07

Study results available
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Summary

The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.

Conditions

  • Breast Cancer
  • Breast Tumors
  • Neoplasms, Breast
  • Cancer of the Breast
  • Human 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.

Sponsors & Collaborators

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Garry Weems, PharmD · Spectrum Pharmaceuticals, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-04-30
Completion
2012-07-31

Countries

  • United States
  • Czechia
  • France
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

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 NCT01118624 on ClinicalTrials.gov