Solid Tumor
Conditions
Keywords
Solid tumor malignancy, excluding lymphoma
Brief summary
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.
Interventions
DRUGTesetaxel plus capecitabine
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.
Sponsors
Genta Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Through 30 days following the last dose of study medication | Percentage of subjects with adverse events |
Countries
United States
Outcome results
None listed