A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer - Full Text View

Sponsored by:	Archer Biosciences, Inc.
Information provided by:	Archer Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00479635

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: TPI 287	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by Archer Biosciences, Inc.:

Primary Outcome Measures:

Response [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment:	26
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

165 mg/m2 every three weeks for six cycles

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479635

Locations

United States, California
Comprehensive Cancer Center at Desert Mountain
Palm Springs, California, United States, 92262
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Missouri
Kansas City Cancer Center South
Kansas City, Missouri, United States, 64131
United States, New Jersey
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Archer Biosciences, Inc.

Investigators

Study Director:

Sandra Silberman, MD, PhD

Archer Biosciences, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	President, Chief Medical Officer ( Sandra Silberman, MD PhD )
Study ID Numbers:	TPI 287-04
Study First Received:	May 24, 2007
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00479635 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Archer Biosciences, Inc.:

HRPC
TPI 287
Taxane
MDR
Hormone Refractory Prostate Cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Taxane
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009