Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Genta Incorporated.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01609127
First received: May 25, 2012
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.


Condition Intervention Phase
Locally Advanced Non-resectable Breast Cancer
Metastatic Breast Cancer
Drug: Tesetaxel
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Response rate [ Time Frame: 4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized ] [ Designated as safety issue: No ]
    the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST [Version 1.1])


Secondary Outcome Measures:
  • Clinical benefit rate [ Time Frame: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized ] [ Designated as safety issue: No ]
    the percentage of patients with a complete or partial response of any duration or stable disease lasting ≥ 6 months

  • Progression-free survival [ Time Frame: 12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized ] [ Designated as safety issue: No ]
    the period from the date of randomization to the date when disease progression is first documented or when the patient dies within 6 weeks of the last lesion assessment

  • Progression-free survival rate [ Time Frame: 6 and 12 months after patients' date of randomization ] [ Designated as safety issue: No ]
    the percentage of patients who are progression free

  • Adverse events [ Time Frame: up to 30 days after patients' last dose of study medication ] [ Designated as safety issue: Yes ]
    the percentage of patients with adverse events classified by term and body system


Estimated Enrollment: 213
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesetaxel every 3 weeks
Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle
Drug: Tesetaxel
Tesetaxel 27 mg/m2 orally once on Day 1 of each 21-day cycle
Experimental: Tesetaxel weekly
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 in a 28-day cycle
Drug: Tesetaxel
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 of each 28-day cycle
Active Comparator: Capecitabine
Capecitabine 1250 mg/m2 orally twice daily (equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 in a 21-day cycle
Drug: Capecitabine
Capecitabine 1250 mg/m2 orally twice daily (in the morning and evening after a meal; equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 of each 21-day cycle
Other Name: Xeloda

  Eligibility

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

Key inclusion criteria:

  1. Female
  2. At least 18 years of age
  3. Locally advanced non-resectable or metastatic breast cancer
  4. HER2 negative disease
  5. Measurable disease per revised RECIST, Version 1.1
  6. Eastern Cooperative Oncology Group performance status 0 or 1
  7. Chemotherapy naïve, OR 1 prior chemotherapy regimen in the neoadjuvant or adjuvant setting provided the patient has had a disease-free interval of ≥ 12 months after ending this chemotherapy. If the neoadjuvant or adjuvant chemotherapy included a taxane, ≥ 2 years must have passed since this treatment ended.
  8. Documented disease recurrence or progression
  9. Adequate bone marrow, hepatic, and renal function
  10. Ability to swallow an oral solid-dosage form of medication
  11. Written informed consent

Key exclusion criteria:

  1. Known metastasis to the central nervous system
  2. Other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ
  3. Significant medical disease other than breast cancer
  4. Presence of neuropathy > Grade 1 (NCI CTC)
  5. History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
  6. History of severe or unexpected reaction to fluoropyrimidine therapy
  7. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
  8. Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway
  9. Known dihydropyrimidine dehydrogenase deficiency
  10. Pregnancy or lactation
  Contacts and Locations
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: NCT01609127

Locations
United States, Tennessee
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Tracy B Stewart, RN, BSN, OCN, CCRC    901 683-0055 ext 1236    tstewart@WESTCLINIC.com   
Principal Investigator: Lee S Schwartzberg, MD, FACP         
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Andrew D Seidman, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01609127     History of Changes
Other Study ID Numbers: TOB206
Study First Received: May 25, 2012
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014