Prostate CancerPhase 2NCT00479635
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer
A Phase 2 study testing TPI 287 in people with Prostate Cancer, run by Cortice Biosciences, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TPI 287
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Kansas City Cancer Center South
Kansas City, Missouri, 64131
University of Kentucky
Lexington, Kentucky, 40536
St. Barnabas Medical Center
Livingston, New Jersey, 07039
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Comprehensive Cancer Center at Desert Mountain
Palm Springs, California, 92262
About this 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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- TPI 287
- Keywords
- HRPC, TPI 287, Taxane, MDR, Hormone Refractory Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI 287Drug
160 mg/m2 every three weeks for six cycles
TPI 287Drug
160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
| Study group | Role | What they receive |
|---|---|---|
| TPI 287 | Experimental | Not described Receives: Drug: TPI 287 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Measured: 15 months
Secondary outcomes (3)
Time to progression
Measured: 15 months
Duration of response
Measured: 6 months
Safety
Measured: Continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Sponsor could no longer support; enrollment stopped August 2008.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortice Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Silberman, MD, PhD, Study director, SLS Oncology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479635
- Sponsor's protocol ID
- TPI 287-04
- Status last verified
- Jan 2014
- First submitted
- 24 May 2007
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00479635
- Acronym / sponsor ID
- TPI 287-04
- Conditions
- Prostate Cancer
- Keywords
- HRPC, TPI 287, Taxane, MDR, Hormone Refractory Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor could no longer support; enrollment stopped August 2008.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cortice Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPI 287 | Experimental | Drug: TPI 287 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPI 287160 mg/m2 every three weeks for six cycles | Drug | TPI 287 |
| TPI 287160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease. | Drug | TPI 287 |
Primary outcome
Response
Time frame: 15 months
3 secondary outcomes
Time to progression
Time frame: 15 months
Duration of response
Time frame: 6 months
Safety
Time frame: Continuous
Results and safety
The study was stopped early (reason given: Sponsor could no longer support; enrollment stopped August 2008.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Silberman, MD, PhD study director
SLS Oncology, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPI 287 in people with Prostate Cancer, run by Cortice Biosciences, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor could no longer support; enrollment stopped August 2008.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.