Expired Study
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Memphis, Tennessee 38120


Purpose:

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.


Criteria:

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


NCT ID:

NCT01315431


Primary Contact:

Principal Investigator
Lee S Schwartzberg, MD, FACP
The West Clinic


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38120
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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