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A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer


Key

Inclusion Criteria:



- At least 18 years of age

- Histologically confirmed prostate cancer, currently with progressive disease

- Evidence of metastatic disease

- Castrate level of testosterone (< 50 ng/dL)

- Eastern Cooperative Oncology Group performance status 0 or 1

- Chemotherapy-naïve

- Adequate bone marrow, hepatic, and renal function

- Ability to swallow an oral solid-dosage form of medication

Key Exclusion Criteria:

- History or presence of brain metastasis or leptomeningeal disease

- Operable cancer

- Uncontrolled diarrhea

- Uncontrolled nausea or vomiting

- Known malabsorptive disorder

- Currently active second malignancy other than non-melanoma skin cancers

- Human immunodeficiency virus (HIV) infection based on history of positive serology

- Significant medical disease other than cancer

- Presence of neuropathy > Grade 2 (National Cancer Institute Common Toxicity Criteria
[NCI CTC]; v4.0)

- Need for other anticancer treatment

- Need to continue any regularly-taken medication that is a potent inhibitor or inducer
of the CYP3A pathway or P-glycoprotein activity

- 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 or P-glycoprotein
activity

- Less than 4 weeks since use of another investigational agent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months from the start of treatment

Safety Issue:

No

Principal Investigator

Michael J Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TOP205

NCT ID:

NCT01296243

Start Date:

February 2011

Completion Date:

February 2015

Related Keywords:

  • Prostate Cancer
  • Castration-resistant prostate cancer
  • Tesetaxel
  • Taxanes
  • Chemotherapy-naive
  • Chemotherapy-exposed
  • Progressive, metastatic castration-resistant prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
University of Michigan Health System Ann Arbor, Michigan  
University of Wisconsin Carbone Cancer Center Madison, Wisconsin  53792-5669