Overview

Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer

Status:
Withdrawn
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase II, open-label study that evaluates the safety and efficacy of IMMU-132 alone and in combination with carboplatin in patients with triple-negative breast cancer. IMMU132 will be administered once-weekly for the first 2 weeks of 3-week treatment cycles. For those patients assigned to also receive carboplatin, will receive it on the same schedules starting 30 minutes after the completion of IMMU-132 administration. Patients may receive up to a maximum total of 8 cycles.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Immunomedics, Inc.
Treatments:
Camptothecin
Carboplatin
Immunoconjugates
Criteria
Inclusion Criteria:

- Female subjects with triple negative metastatic breast cancer, age 18 years or older,
pathologically confirmed metastatic adenocarcinoma of the breast. Pathologically
confirmed as triple-negative, measurable disease, defined by (RECIST 1.1) guidelines;

- Two or more prior chemotherapy, immunotherapy and/or monoclonal antibody therapy for
the treatment of the subjects' metastatic breast cancer;

- Prior neoadjuvant or adjuvant chemotherapy must have been completed at least 4 weeks
before start of study treatment with all related toxicities resolved;

- Prior radiotherapy must have completed at least 2 weeks before randomization, with
full recovery;

- At least 4 weeks from major surgery, ECOG performance status 0-1.

- Hematology parameters (ANC) ≥ 1500/mm2;

- Platelets ≥ 100,000/mm2;

- Hemoglobin (Hgb) ≥ 9 g/dL AST & ALT ≤ 2.5 x ULN);

- If hepatic metastases present ≤ 5.0 x ULN Total bilirubin ≤ ULN ;

- Subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN;

- Alkaline phosphatase ≤ 2.5 x ULN (unless bone metastases are present in the absence of
liver metastasis);

- Creatinine clearance > 60 mL/min

Exclusion Criteria:

- Male subjects with triple negative metastatic breast cancer;

- Concurrent chemotherapy, immunotherapy or monoclonal antibody or any other anti-tumor
therapy for breast cancer,

- Concurrent or prior anticoagulation therapy within 7 days of first dose of study
treatment,

- History of, or known current evidence of brain metastasis, including leptomeningeal
involvement;

- Subjects with bone as the only site of metastatic disease.