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A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01315431
Recruitment Status : Unknown
Verified July 2012 by Genta Incorporated.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2011
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
Genta Incorporated

Tracking Information
First Submitted Date  ICMJE March 11, 2011
First Posted Date  ICMJE March 15, 2011
Last Update Posted Date July 24, 2012
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
Incidence of adverse events [ Time Frame: Through 30 days following the last dose of study medication ]
Percentage of subjects with adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01315431 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
Official Title  ICMJE A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Tesetaxel-capecitabine
Intervention: Drug: Tesetaxel plus capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 14, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01315431
Other Study ID Numbers  ICMJE TOST107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genta Incorporated
Study Sponsor  ICMJE Genta Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee S Schwartzberg, MD, FACP The West Clinic
PRS Account Genta Incorporated
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP