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