A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.

Inclusion Criteria:

• At least 18 years of age
• Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma
• Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.)
• ECOG performance status of 0 or 1
• Adequate bone marrow, hepatic, and renal function
• At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1

Exclusion Criteria:

• Brain metastasis or leptomeningeal disease
• Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years)
• Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection
• Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study
• Significant medical disease other than cancer
• Neuropathy at least Grade 2
• Difficulty swallowing
• Malabsorptive disorder
• Need for other anticancer treatment while receiving study medication
• Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication.
• Pregnancy or lactation
• History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components