NCT00479635

Brief Summary

The primary objective of the study is to determine the response rate to TPI 287 in patients with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

6 active sites

Status
terminated

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

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

May 24, 2007

Last Update Submit

January 9, 2014

Conditions

Prostate Cancer

Keywords

HRPCTPI 287TaxaneMDRHormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Response

    15 months

Secondary Outcomes (3)

  • Time to progression

    15 months

  • Duration of response

    6 months

  • Safety

    Continuous

Study Arms (1)

TPI 287

EXPERIMENTAL
Drug: TPI 287

Interventions

TPI 287DRUG

160 mg/m2 every three weeks for six cycles

TPI 287

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological evidence of adenocarcinoma of the prostate and have metastatic disease.
  • Patients must have received only one prior regimen for their advanced disease. This regimen must have included a taxane.
  • First Stratum Eligibility: Patients must have advanced, metastatic prostate cancer with documented progression after receiving more than three months of treatment, up to a total of 10 months with 1 prior taxane regimen. Prior best response to treatment, and duration of response, will be recorded.
  • Second Stratum Eligibility: Patients must have advanced, metastatic prostate cancer that has progressed as best response despite three months or less of treatment with 1 prior taxane regimen.
  • Must have castrate levels of testosterone less than 50 ng/mL
  • Must have an ECOG Performance Score of 0 or 1
  • Must be age 18 or older
  • Must be able to read, understand and sign informed consent
  • Serum creatinine less than or equal to 2.0 mg/dL
  • Total bilirubin less than or equal to 2.0 mg/dL
  • SGOT/SGPT less than or equal to 3 times the ULN
  • ANC greater than or equal to 1500/UL
  • Platelet count greater than or equal to 100,000/UL Recovered from the effects of prior surgery, radiotherapy or other antineoplastic therapy.

You may not qualify if:

  • Active infection or with a fever greater than or equal to 38.5 degrees centigrade within 3 days of first scheduled day of dosing
  • More than one prior systemic therapy for HRPC beyond androgen-ablative therapy. Prior systemic therapy may have been administered for metastatic disease or as adjuvant therapy
  • Has received radiotherapy to greater than 30% of their active bone marrow
  • History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancer
  • Impending fracture of a weight bearing bone
  • Known hypersensitivity to any of the components of TPI 287
  • Receiving concurrent investigational therapy or who have received investigational therapy within 30 days of study start
  • Grade 2 peripheral neuropathy
  • NYHA Class 3 or 4 congestive heart failure
  • Any medial condition that would interfere with ability to sign ICF, cooperate and participate in the study or interfere with interpretation of results
  • History of allogenic transplant
  • Know HIV or Hepatitis B or C positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Comprehensive Cancer Center at Desert Mountain

Palm Springs, California, 92262, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Kansas City Cancer Center South

Kansas City, Missouri, 64131, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

TPI-287

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sandra Silberman, MD, PhD

    SLS Oncology, LLC

    STUDY DIRECTOR

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

May 24, 2007

First Posted

May 28, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(6)