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

Primary Purpose

Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tesetaxel

Capecitabine

About this trial

This is an interventional treatment trial for Locally Advanced Non-resectable Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key inclusion criteria:

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

Key exclusion criteria:

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

Sites / Locations

The West ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Tesetaxel every 3 weeks

Tesetaxel weekly

Capecitabine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

Clinical benefit rate

the percentage of patients with a complete or partial response of any duration or stable disease lasting ≥ 6 months

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

Progression-free survival rate

the percentage of patients who are progression free

Adverse events

the percentage of patients with adverse events classified by term and body system

Full Information

NCT ID

NCT01609127

First Posted

May 25, 2012

Last Updated

May 31, 2012

Sponsor

Genta Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01609127

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genta Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tesetaxel every 3 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

Tesetaxel weekly

Arm Type

Experimental

Arm Description

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

Arm Title

Capecitabine

Arm Type

Active Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Tesetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tesetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Primary Outcome Measure Information:

Title

Response rate

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])

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

Secondary Outcome Measure Information:

Title

Clinical benefit rate

Description

the percentage of patients with a complete or partial response of any duration or stable disease lasting ≥ 6 months

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

Title

Progression-free survival

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

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

Title

Progression-free survival rate

Description

the percentage of patients who are progression free

Time Frame

6 and 12 months after patients' date of randomization

Title

Adverse events

Description

the percentage of patients with adverse events classified by term and body system

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key inclusion criteria: 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 Key exclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew D Seidman, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The West Clinic

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tracy B Stewart, RN, BSN, OCN, CCRC

Phone

901 683-0055

Ext

1236

tstewart@WESTCLINIC.com

First Name & Middle Initial & Last Name & Degree

Lee S Schwartzberg, MD, FACP

12. IPD Sharing Statement

Learn more about this trial

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

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