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
Information provided by (Responsible Party):
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.
Drug: Tesetaxel plus capecitabine
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315431
|The West Clinic
|Memphis, Tennessee, United States, 38120 |
||Lee S Schwartzberg, MD, FACP
||The West Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 11, 2011
||July 23, 2012
||United States: Food and Drug Administration
Keywords provided by Genta Incorporated:
Solid tumor malignancy, excluding lymphoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 27, 2016
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs