A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01315431
• Other study ID #: TOST107
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 11, 2011
• Last updated: July 23, 2012
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The West Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Percentage of subjects with adverse events	Through 30 days following the last dose of study medication	Yes