- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479635
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer
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 Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
Palm Springs, California, United States, 92262
- Comprehensive Cancer Center at Desert Mountain
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky
-
-
Missouri
-
Kansas City, Missouri, United States, 64131
- Kansas City Cancer Center South
-
-
New Jersey
-
Livingston, New Jersey, United States, 07039
- St. Barnabas Medical Center
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TPI 287
|
160 mg/m2 every three weeks for six cycles
160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response
Time Frame: 15 months
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of response
Time Frame: 6 months
|
6 months
|
Safety
Time Frame: Continuous
|
Continuous
|
Time to progression
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sandra Silberman, MD, PhD, SLS Oncology, LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPI 287-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on TPI 287
-
Giselle ShollerCortice Biosciences, Inc.TerminatedMedulloblastoma | NeuroblastomaUnited States
-
University of California, San FranciscoTau Consortium; CBD SolutionsCompletedProgressive Supranuclear Palsy (PSP) | Corticobasal Degeneration (CBD) | Corticobasal Syndrome (CBS) | Primary Four Repeat Tauopathies (4RT)United States
-
University of California, San FranciscoCompletedAlzheimer's DiseaseUnited States
-
Giselle ShollerCortice Biosciences, Inc.CompletedMedulloblastoma | Neuroblastoma | RelapseUnited States
-
M.D. Anderson Cancer CenterCortice Biosciences, Inc.Terminated
-
M.D. Anderson Cancer CenterCortice Biosciences, Inc.Withdrawn
-
Cortice Biosciences, Inc.SuspendedGlioblastoma MultiformeUnited States
-
Cortice Biosciences, Inc.TerminatedGlioblastoma MultiformeUnited States
-
Cortice Biosciences, Inc.CompletedNeoplasms | Hodgkin Disease | Non-Hodgkin LymphomaUnited States
-
Cortice Biosciences, Inc.CompletedNeoplasms | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States