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

This study is currently recruiting participants.
Verified May 2012 by Genta Incorporated
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

May 25, 2012
May 31, 2012
May 2012
September 2013   (final data collection date for primary outcome measure)
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])
Same as current
Complete list of historical versions of study NCT01609127 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Locally Advanced Non-resectable Breast Cancer
  • Metastatic Breast Cancer
  • Drug: Tesetaxel
    Tesetaxel 27 mg/m2 orally once on Day 1 of each 21-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
  • 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
  • Experimental: Tesetaxel every 3 weeks
    Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle
    Intervention: Drug: Tesetaxel
  • 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
    Intervention: Drug: Tesetaxel
  • 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
    Intervention: Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
213
July 2014
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Not Provided
United States
 
NCT01609127
TOB206
No
Genta Incorporated
Genta Incorporated
Not Provided
Principal Investigator: Andrew D Seidman, MD Memorial Sloan-Kettering Cancer Center
Genta Incorporated
May 2012

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