Recruiting
Phase 2

Tesetaxel

Sponsor:

Genta Incorporated

Code:

NCT01221870

Conditions

Breast Neoplasm

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tesetaxel once every 3 weeks

Tesetaxel once weekly

Study Details

Brief summary:

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.

Conditions

Breast Neoplasm

Study ID

NCT01221870

Start date

Nov, 2010

Status verified date

Jul, 2012

Completion date

Jan, 2013

Anticipated

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

81 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tesetaxel once every 3 weeks

Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months

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

Interventions

Tesetaxel once every 3 weeks

Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months

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

Primary outcome measure

  • Response rate (revised RECIST) [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]

Central Contacts and Locations

Locations

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Andrew D Seidman, MD

646-888-4559

Principal Investigator:

Andrew D Seidman, MD

The Moses H. Cone Regional Cancer Center

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Peter Rubin, MD

336-832-1100

Principal Investigator:

Peter Rubin, MD

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Joyce O'Shaughnessy, MD

joyce.oshaughnessy@usoncology.com

Principal Investigator:

Joyce O'Shaughnessy, MD

More Information

Sponsor

Genta Incorporated

Last update posted

Jul 24, 2012

Last verified

Jul, 2012

Keywords

  • Metastatic breast cancer
  • First-line therapy
  • Tesetaxel
  • Oral taxane

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genta Incorporated on 2012-07-24.