A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Genta Incorporated.
Recruitment status was  Active, not recruiting
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

March 11, 2011
July 23, 2012
March 2011
August 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01315431 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor
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
Experimental: Tesetaxel-capecitabine
Intervention: Drug: Tesetaxel plus capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9
October 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01315431
TOST107
No
Genta Incorporated
Genta Incorporated
Not Provided
Principal Investigator: Lee S Schwartzberg, MD, FACP The West Clinic
Genta Incorporated
July 2012

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