Clinical trial · Interventional
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
NCT00479635CI-TRIAL-00013522terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor could no longer support; enrollment stopped August 2008.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TPI 287 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPI 287
- interventionNames
- Drug: TPI 287
Primary outcomes (1)
- measure
- Response
- timeFrame
- 15 months
Secondary outcomes (3)
- measure
- Time to progression
- timeFrame
- 15 months
- measure
- Duration of response
- timeFrame
- 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.