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.

Study Overview

• Status: Unknown
• Conditions: Metastatic Breast Cancer; Locally Advanced Non-resectable Breast Cancer
• Intervention / Treatment: Drug: Tesetaxel; Drug: Tesetaxel; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 213
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • The West Clinic
      • Contact: Tracy B Stewart, RN, BSN, OCN, CCRC; Phone Number: 1236 901 683-0055; Email: tstewart@WESTCLINIC.com
      • Principal Investigator: Lee S Schwartzberg, MD, FACP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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 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
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 Names: Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Progression-free survival rate	the percentage of patients who are progression free	6 and 12 months after patients' date of randomization
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

Collaborators and Investigators

• Sponsor: Genta Incorporated

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: TOB206