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A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01315431
First received: March 11, 2011
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315431

Locations
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Genta Incorporated
Investigators
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:
Neoplasms
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
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 May 16, 2013