Study of ABT-700 in Subjects With Advanced Solid Tumors

Inclusion Criteria:

• Subject with advanced solid tumors.
• Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
• Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
• Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: subjects must have inoperable, locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2) -negative gastric/gastroesophageal junction adenocarcinoma with no prior therapy for metastatic disease and be eligible to receive oxaliplatin and capecitabine (XELOX) in combination with ABT-700.

Exclusion Criteria:

• Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.
• Palliative radiation therapy for painful bony or skin metastasis for 10 fractions or less is not subject to a washout period.
• Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
• Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following: subjects with inoperable, locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma, who are ineligible to receive XELOX chemotherapy, who are HER2+, or who have received prior chemotherapy for metastatic disease will be excluded (adjuvant treatment with chemotherapy/radiation therapy ≥ 6 months from Cycle 1 Day 1 is allowed).