A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
First received: March 11, 2011
Last updated: July 23, 2012
Last verified: July 2012

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.

Condition Intervention Phase
Solid Tumor
Drug: Tesetaxel plus capecitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

Resource links provided by NLM:

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 30 days following the last dose of study medication ] [ Designated as safety issue: Yes ]
    Percentage of subjects with adverse events

Estimated Enrollment: 9
Study Start Date: March 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesetaxel-capecitabine 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.

Other Names:
  • DJ-927
  • Xeloda


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315431

United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Genta Incorporated
Principal Investigator: Lee S Schwartzberg, MD, FACP The West Clinic
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01315431     History of Changes
Other Study ID Numbers: TOST107
Study First Received: March 11, 2011
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Solid tumor malignancy, excluding lymphoma

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014