Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer, with or without Brain Metastases

This is a Phase 1/2a study designed to evaluate the safety and tolerability of increased repeated doses of LYC-55716 in subjects with locally advanced or metastatic solid tumors.

Inclusion Criteria:
• Histological or cytological confirmation of advanced unresectable solid tumors, including those subjects who have progressed on standard anticancer therapy and for whom no further therapy that confers clinical benefit is available.
• Subject has an Eastern Cooperative Oncology Group (ECOG) score of 0 1 or Karnofsky Performance Status Score ≥ 70.
• Subject has a life expectancy of at least 12 weeks.
• Subject has adequate organ function as determined by the following laboratory values:
Absolute Neutrophil Count ≥ 1,500/mm3 (≥ 1.5 x 109/L)
Platelets ≥ 100,000/mm3 (≥ 100 x 109/L)
Lymphocytes ≥ 0.5 x 109/L
Hemoglobin > 9.0 g/dL
Serum Creatinine or Creatinine Clearance ≤ 1.5 x ULN, > 50 mL/min
Total Serum Bilirubin ≤ 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
Liver Transaminases (ALT/AST) ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver metastases present

Exclusion Criteria:
• Subject has received an investigational drug in the 28 day period before the first dose of study drug or is currently participating in another interventional clinical trial.
• Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible if they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.
• Subject has not recovered from adverse reactions to prior cancer treatment or procedures to CTCAE Grade 2 or better.
• Subject has a previous or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.
Phase II
Gary Goodman, M.D.
SWOG (Southwest Oncology Group)
Nikki Moxon

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.