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A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TPI 287
TPI 287
Sponsored by
Cortice Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring HRPC, TPI 287, Taxane, MDR, Hormone Refractory Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Comprehensive Cancer Center at Desert Mountain
  • University of Kentucky
  • Kansas City Cancer Center South
  • St. Barnabas Medical Center
  • Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPI 287

Arm Description

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Time to progression
Duration of response
Safety

Full Information

First Posted
May 24, 2007
Last Updated
January 9, 2014
Sponsor
Cortice Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00479635
Brief Title
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer
Official Title
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Taxane Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor could no longer support; enrollment stopped August 2008.
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cortice Biosciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is an open-label, multi-center, 2-stage Simon design, Phase 2 study of TPI 287 in patients with metastatic, hormone-refractory prostate cancer. All patients must have received prior taxane therapy. Up to 80 patients will be enrolled and stratified based on duration of cumulative exposure to a single prior taxane regimen. A single taxane regimen is considered to he a taxane or taxane containing therapy administered on a defined schedule with no more than 2 months' interruption between treatments, and total exposure will be assessed by the number of months on that schedule. One stratum (up to 40 patients) will consist of patients who have had over 3 months (up to a maximum of 10 months) exposure to a taxane regimen, who then have documented progression of disease (initially taxane sensitive). The second stratum (up to 40 patients) will consist of patients considered primarily resistant to taxanes who have had documented progressive disease as best response after exposure to a single taxane regimen for less than or equal to 3 months. Patients may have received prior hormonal therapy and/or bisphosphonates and may continue on these therapies. In the first stage of the trial, 22 patients in each stratum will be treated with TPI 287 intravenously every 21 days. If 1 or fewer patients in either stratum demonstrate a response in this first stage, the trial will be discontinued for that stratum. Otherwise, an additional 18 patients in the stratum showing 2 or more responses will be enrolled in the second stage of the study. If 4 or fewer patients demonstrate a response in the total study population in either stratum from stages 1 and 2, then the drug will not be considered of interest in prostate cancer for patients as defined in that stratum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
HRPC, TPI 287, Taxane, MDR, Hormone Refractory Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPI 287
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TPI 287
Intervention Description
160 mg/m2 every three weeks for six cycles
Intervention Type
Drug
Intervention Name(s)
TPI 287
Intervention Description
160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
Primary Outcome Measure Information:
Title
Response
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
15 months
Title
Duration of response
Time Frame
6 months
Title
Safety
Time Frame
Continuous

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Silberman, MD, PhD
Organizational Affiliation
SLS Oncology, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Comprehensive Cancer Center at Desert Mountain
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kansas City Cancer Center South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.archerbio.com/
Description
Related Info

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A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer

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