A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

NCT01315431 | Unknown Phase 1

• 1 other identifier: TOST107
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Percentage of subjects with adverse events

  Through 30 days following the last dose of study medication

Study Arms (1)

Tesetaxel-capecitabine

EXPERIMENTAL

Drug: Tesetaxel plus capecitabine

Interventions

Tesetaxel plus capecitabine 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.

Also known as: DJ-927, Xeloda

Tesetaxel-capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

The West Clinic

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Interventions

tesetaxel; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lee S Schwartzberg, MD, FACP

  The West Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

US (1)