NCT01296243

Brief Summary

Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

February 10, 2011

Last Update Submit

July 20, 2012

Conditions

Prostate Cancer

Keywords

Castration-resistant prostate cancerTesetaxelTaxanesChemotherapy-naiveChemotherapy-exposedProgressive, metastatic castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    6 months from the start of treatment

Secondary Outcomes (8)

  • Response rate (RECIST 1.1) among patients with measurable disease

    6 months from the start of treatment

  • Duration of response among patients with measurable disease

    12 months from the start of treatment

  • Durable response among patients with measurable disease

    12 months from the start of treatment

  • Overall survival

    3 years following enrollment of the last subject

  • Disease-control rate

    6 months from the start of treatment

  • +3 more secondary outcomes

Study Arms (1)

Tesetaxel once every 3 weeks

EXPERIMENTAL
Drug: Tesetaxel

Interventions

TesetaxelDRUG

Tesetaxel capsules will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability.

Also known as: DJ-927
Tesetaxel once every 3 weeks

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Michigan Health System

Ann Arbor, Michigan, 48109-5946, United States

RECRUITING

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tesetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michael J Morris, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 15, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

February 1, 2015

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

US(4)