Previously-treated Advanced or Metastatic Breast Cancer MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Allos Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has participated in an Allos-sponsored clinical study that included pralatrexate and has not met treatment discontinuation criteria as defined in the original clinical study protocol. 2. Patient agrees to continue vitamin supplementation as defined in the original clinical study protocol. 3. Females of childbearing potential must be practicing a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of study treatment. 4. Males who are sexually active must agree to practice a medically acceptable barrier method contraceptive regimen while receiving study treatment and for 30 days after the last administration of study treatment. 5. Patient has given written informed consent (IC). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Patient has medical illness or unstable medical condition that may interfere with the ability to interpret the IC or safety information. 2. Patient has received subsequent therapy for the disease being studied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Allow continued treatment with assigned drug of patients who have participated in an Allos-sponsored clinical study that is closing as a result of meeting its objectives and/or endpoints and for which all patients in the study have completed a final study assessment.;Secondary Objective: Evaluate the safety of extended study treatment in patients who have received clinical benefit from participation in an Allos-sponsored pralatrexate clinical study that is closing as a result of meeting its objectives and/or endpoints. Observe the efficacy of extended study treatment in patients who have received clinical benefit from participation in an Allos-sponsored pralatrexate clinical study that is closing as a result of meeting its objectives and/or endpoints.;Primary end point(s): Long-term safety and efficacy;Timepoint(s) of evaluation of this end point: Over the period of participation in the study - patient will continue on pralatrexate until 1 of the criteria for study treatment discontinuation, defined in the protocol, is met. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Hungary, United States
Contacts
Public ContactLiz McCann, Senior Vice-President
European Medical Advisory Services Ltd. (EMAS)
Outcome results
None listed