A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genta Incorporated
• Treatments: Capecitabine

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