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

Metastatic Breast Cancer Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01609127
• Other study ID #: TOB206
• Status: Recruiting
• Phase: Phase 2
• First received: May 25, 2012
• Last updated: May 31, 2012
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: May 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: July 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tesetaxel
Tesetaxel 27 mg/m2 orally once on Day 1 of each 21-day cycle
• 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
• 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

Locations

Country	Name	City	State
United States	The West Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	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])	4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized	No
Secondary	Clinical benefit rate	the percentage of patients with a complete or partial response of any duration or stable disease lasting = 6 months	12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized	No
Secondary	Progression-free survival	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	12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized	No
Secondary	Progression-free survival rate	the percentage of patients who are progression free	6 and 12 months after patients' date of randomization	No
Secondary	Adverse events	the percentage of patients with adverse events classified by term and body system	up to 30 days after patients' last dose of study medication	Yes