Trial Outcomes & Findings for Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer (NCT NCT01118624)
NCT ID: NCT01118624
Last Updated: 2020-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
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.
Results posted on
2020-01-07
Participant Flow
Patients were enrolled between 05 Oct 2009 and 10 May 2011. Patients were enrolled in Hungary, France, and the Czech Republic.
Participant milestones
| Measure |
Pralatrexate
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer
Baseline characteristics by cohort
| Measure |
Pralatrexate
n=22 Participants
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Pralatrexate
n=22 Participants
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Objective Response Rate (ORR)
|
1 participants
Interval 0.1 to 22.8
|
SECONDARY outcome
Timeframe: 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.One patient has a PR as response and duration of response was provided for that patient.
Outcome measures
| Measure |
Pralatrexate
n=1 Participants
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Duration of Response (DOR)
|
112 days
|
SECONDARY outcome
Timeframe: 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.Number of days from first dose of pralatrexate to death.
Outcome measures
| Measure |
Pralatrexate
n=22 Participants
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Overall Survival (OS)
|
11.3 months
Interval 6.8 to 13.9
|
SECONDARY outcome
Timeframe: 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).Outcome measures
| Measure |
Pralatrexate
n=22 Participants
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Incidence of Adverse Events (AEs) and Laboratory Abnormalities
|
21 participants
|
Adverse Events
Pralatrexate
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pralatrexate
n=22 participants at risk
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Gastrointestinal disorders
MUCOSAL INFLAMMATION
|
9.1%
2/22 • Number of events 2 • 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
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
9.1%
2/22 • Number of events 2 • 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
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
9.1%
2/22 • Number of events 2 • 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
|
Other adverse events
| Measure |
Pralatrexate
n=22 participants at risk
Study drug 190 mg/m\^2 for 2 to 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.5%
1/22 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
4.5%
1/22 • Number of events 1 • 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
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
4.5%
1/22 • Number of events 1 • 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
|
|
General disorders
PYREXIA
|
4.5%
1/22 • Number of events 1 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place