Clinical Trials /

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

NCT01609127

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: TOB206
  • NCT ID: NCT01609127

Conditions

  • Locally Advanced Non-resectable Breast Cancer
  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
TesetaxelTesetaxel every 3 weeks
TesetaxelTesetaxel weekly
CapecitabineXelodaCapecitabine

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.

Trial Arms

NameTypeDescriptionInterventions
Tesetaxel every 3 weeksExperimentalTesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle
  • Tesetaxel
Tesetaxel weeklyExperimentalTesetaxel 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
  • Tesetaxel
CapecitabineActive ComparatorCapecitabine 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
  • Capecitabine

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description: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

Measure: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
Safety Issue:
Description:the percentage of patients with a complete or partial response of any duration or stable disease lasting ≥ 6 months
Measure: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
Safety Issue:
Description: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
Measure:Progression-free survival rate
Time Frame:6 and 12 months after patients' date of randomization
Safety Issue:
Description:the percentage of patients who are progression free
Measure:Adverse events
Time Frame:up to 30 days after patients' last dose of study medication
Safety Issue:
Description:the percentage of patients with adverse events classified by term and body system

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Genta Incorporated

Last Updated

May 31, 2012