A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
Status unconfirmed · Phase 1
Conditions studied: Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT01315431
- Run by
- Genta Incorporated
- People needed
- 9
- Starts
- 2011-03-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2012-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The West Clinic — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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