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Trial record 21 of 37 for:    pralatrexate

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

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ClinicalTrials.gov Identifier: NCT01118624
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Breast Tumors
Neoplasms, Breast
Cancer of the Breast
Human Mammary Carcinoma
Interventions Drug: Pralatrexate Injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Enrollment 22
Recruitment Details Patients were enrolled between 05 Oct 2009 and 10 May 2011. Patients were enrolled in Hungary, France, and the Czech Republic.
Pre-assignment Details  
Arm/Group Title Pralatrexate
Hide Arm/Group Description Study drug 190 mg/m^2 for 2 to 4 weeks.
Period Title: Overall Study
Started 22
Completed 0
Not Completed 22
Arm/Group Title Pralatrexate
Hide Arm/Group Description Study drug 190 mg/m^2 for 2 to 4 weeks.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
Patients enrolled and treated with study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
56.4  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
22
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
21
  95.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   4.5%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pralatrexate
Hide Arm/Group Description:
Study drug 190 mg/m^2 for 2 to 4 weeks.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description One patient has a PR as response and duration of response was provided for that patient.
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pralatrexate
Hide Arm/Group Description:
Study drug 190 mg/m^2 for 2 to 4 weeks.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: days
112
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Number of days from first dose of pralatrexate to death.
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pralatrexate
Hide Arm/Group Description:
Study drug 190 mg/m^2 for 2 to 4 weeks.
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
11.3
(6.8 to 13.9)
4.Secondary Outcome
Title Incidence of Adverse Events (AEs) and Laboratory Abnormalities
Hide Description [Not Specified]
Time Frame Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pralatrexate
Hide Arm/Group Description:
Study drug 190 mg/m^2 for 2 to 4 weeks.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
21
Time Frame All treated patients will be followed for safety through 35 (± 5) days after their last dose or until all treatment-related AEs have resolved or returned to baseline/Grade 1, whichever is longer
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pralatrexate
Hide Arm/Group Description Study drug 190 mg/m^2 for 2 to 4 weeks.
All-Cause Mortality
Pralatrexate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pralatrexate
Affected / at Risk (%) # Events
Total   6/22 (27.27%)    
Blood and lymphatic system disorders   
THROMBOCYTOPENIA  1  2/22 (9.09%)  2
Gastrointestinal disorders   
MUCOSAL INFLAMMATION  1  2/22 (9.09%)  2
Respiratory, thoracic and mediastinal disorders   
PLEURAL EFFUSION  1  2/22 (9.09%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pralatrexate
Affected / at Risk (%) # Events
Total   1/22 (4.55%)    
Blood and lymphatic system disorders   
ANAEMIA  1  1/22 (4.55%)  1
FEBRILE NEUTROPENIA  1  1/22 (4.55%)  1
General disorders   
PYREXIA  1  1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pankaj Sharma, MD
Organization: Spectrum Pharmaceuticals
Phone: 949-743-9264
EMail: pankaj.sharma@sppirx.com
Layout table for additonal information
Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01118624     History of Changes
Other Study ID Numbers: PDX-014
2008-006425-14 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: February 24, 2014
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014