Trial Outcomes & Findings for Agatolimod and Trastuzumab in Treating Patients With Locally Advanced or Metastatic Breast Cancer (NCT NCT00824733)
NCT ID: NCT00824733
Last Updated: 2016-01-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
up to 18 weeks
Results posted on
2016-01-14
Participant Flow
Participant milestones
| Measure |
Arm I: Treatment (PF03512676 in Combination With Trastuzumab)
12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Agatolimod and Trastuzumab in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I: Treatment (PF03512676 in Combination With Trastuzumab)
n=6 Participants
12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 18 weeksPopulation: Samples were not analyzed for primary endpoint due to the sample numbers being too small. No data were collected from the samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 weeksProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm I: Treatment (PF03512676 in Combination With Trastuzumab)
n=6 Participants
12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18.
|
|---|---|
|
Progression-free Survival for Patients With Metastatic Breast Cancer That Are Receiving Trastuzumab Plus PF-03512676
|
13 weeks
Interval 7.0 to 16.0
|
SECONDARY outcome
Timeframe: up to 18 weeksPopulation: The study was terminated early due to poor patient accrual and no data was collected and analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Arm I: Treatment (PF03512676 in Combination With Trastuzumab)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Treatment (PF03512676 in Combination With Trastuzumab)
n=6 participants at risk
12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18.
|
|---|---|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Number of events 1 • Adverse events were graded using the NCI Common Toxicity Criteria (CTC) version 3.0.
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Number of events 1 • Adverse events were graded using the NCI Common Toxicity Criteria (CTC) version 3.0.
|
Other adverse events
| Measure |
Arm I: Treatment (PF03512676 in Combination With Trastuzumab)
n=6 participants at risk
12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18.
|
|---|---|
|
General disorders
fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events were graded using the NCI Common Toxicity Criteria (CTC) version 3.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Number of events 3 • Adverse events were graded using the NCI Common Toxicity Criteria (CTC) version 3.0.
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Number of events 2 • Adverse events were graded using the NCI Common Toxicity Criteria (CTC) version 3.0.
|
Additional Information
Bhuvaneswari Ramaswamy, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place