A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Tesetaxel plus capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesetaxel-capecitabine<br> | Drug: Tesetaxel plus capecitabine<br>* Study medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14. At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol.<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Percentage of subjects with adverse events | Through 30 days following the last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor malignancy, excluding lymphoma