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• Status: Withdrawn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.