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

NCT01609127 | Unknown Phase 2

• 1 other identifier: TOB206
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Non-resectable Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical benefit rate

  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

  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

  6 and 12 months after patients' date of randomization

• Adverse events

  up to 30 days after patients' last dose of study medication

Study Arms (3)

Tesetaxel every 3 weeks

EXPERIMENTAL

Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle

Drug: Tesetaxel

Tesetaxel weekly

EXPERIMENTAL

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

Capecitabine

ACTIVE COMPARATOR

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

Interventions

Tesetaxel DRUG

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

Tesetaxel every 3 weeks

Capecitabine DRUG

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

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• At least 18 years of age
• Locally advanced non-resectable or metastatic breast cancer
• HER2 negative disease
• Measurable disease per revised RECIST, Version 1.1
• Eastern Cooperative Oncology Group performance status 0 or 1
• 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.
• Documented disease recurrence or progression
• Adequate bone marrow, hepatic, and renal function
• Ability to swallow an oral solid-dosage form of medication
• Written informed consent

You may not qualify if:

• Known metastasis to the central nervous system
• 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
• Significant medical disease other than breast cancer
• Presence of neuropathy \> Grade 1 (NCI CTC)
• History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
• History of severe or unexpected reaction to fluoropyrimidine therapy
• Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
• 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
• Known dihydropyrimidine dehydrogenase deficiency
• Pregnancy or lactation

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

The West Clinic

Memphis, Tennessee, 38120, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tesetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Andrew D Seidman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: July 1, 2014
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (1)