A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

Phase 1

• Conditions: Solid Tumor
• Interventions: Drug: Tesetaxel plus capecitabine

• Registration Number: NCT01315431
• Lead Sponsor: Genta Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24
• Primary Completion: 2012-08
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tesetaxel-capecitabine	Tesetaxel plus capecitabine	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through 30 days following the last dose of study medication	Percentage of subjects with adverse events

Trial Locations

Locations (1)

The West Clinic; 🇺🇸 Memphis, Tennessee, United States