Tesetaxel as First-line Therapy for Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Genta Incorporated.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01221870
First received: October 13, 2010
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer.

Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.


Condition Intervention Phase
Breast Neoplasm
Drug: Tesetaxel once every 3 weeks
Drug: Tesetaxel once weekly
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Response rate (revised RECIST) [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of patients with a confirmed complete or partial response


Secondary Outcome Measures:
  • Disease control rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration

  • Progression-free rate [ Time Frame: 6 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of patients without disease progression 6 months following the first dose of study medication

  • Durable response rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of patients with a confirmed complete or partial response ≥ 6 months in duration

  • Duration of response [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Date when response criteria are first met to the date when progression is first documented

  • Time to progression [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Date of first dose of study medication to the date when progression is first documented

  • Adverse events [ Time Frame: Up to 30 days after the last dose of study medication for a specific patient ] [ Designated as safety issue: Yes ]
    Incidence of adverse events


Estimated Enrollment: 81
Study Start Date: November 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesetaxel once every 3 weeks
Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months
Drug: Tesetaxel once every 3 weeks
Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
Other Name: DJ-927
Experimental: Tesetaxel once weekly
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months
Drug: Tesetaxel once weekly
Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months
Other Name: DJ-927

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria:

  • Female
  • At least 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Stage IV disease
  • HER2 status negative
  • Measurable disease (revised RECIST; Version 1.1)
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Life expectancy of at least 3 months
  • Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
  • Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
  • Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
  • Adequate bone marrow, hepatic, and renal function, as specified in the protocol
  • At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
  • Ability to swallow an oral solid-dosage form of medication

Primary Exclusion Criteria:

  • Known metastasis to the central nervous system
  • History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
  • Significant medical disease other than Stage IV breast cancer
  • Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
  • History of hypersensitivity to a taxane
  • Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221870

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew D Seidman, MD    646-888-4559      
Principal Investigator: Andrew D Seidman, MD         
United States, North Carolina
The Moses H. Cone Regional Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Peter Rubin, MD    336-832-1100      
Principal Investigator: Peter Rubin, MD         
United States, Tennessee
The West Clinic Active, not recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Joyce O'Shaughnessy, MD       joyce.oshaughnessy@usoncology.com   
Principal Investigator: Joyce O'Shaughnessy, MD         
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Andrew D Seidman, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01221870     History of Changes
Other Study ID Numbers: TOB203
Study First Received: October 13, 2010
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Metastatic breast cancer
First-line therapy
Tesetaxel
Oral taxane

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014