A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

NCT ID: NCT01315431

Last Updated: 2012-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-10-31

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.

Conditions

Solid Tumor

Keywords

Solid tumor malignancy, excluding lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tesetaxel-capecitabine

Group Type: EXPERIMENTAL

Tesetaxel plus capecitabine

Intervention Type: DRUG

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.

Interventions

Tesetaxel 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.

Intervention Type: DRUG

Other Intervention Names

DJ-927; Xeloda

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee S Schwartzberg, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

The West Clinic

Locations

The West Clinic

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

TOST107

Identifier Type: -

Identifier Source: org_study_id