Clinical trial · Interventional
SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel
A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
NCT00096499CI-TRIAL-00009151completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well SB-715992 works in treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ispinesib | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ispinesib)
- description
- Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: ispinesib
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Probability of PSA response
- timeFrame
- Up to 3 years
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- From date of registration to date of death due to any cause, assessed up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic disease (N1 and/or M1)
* Unresponsive or refractory to androgen-deprivation therapy
* Must have received one, and only one, prior taxane-containing (docetaxel or paclitaxel) chemotherapy regimen for metastatic disease that was discontinued due to disease progression, intolerance, or patient request
* Evidence of disease progression as defined by ≥ 1 of the following:
* Progression of measurable disease
* Progression of evaluable disease
* Rising prostate-specific antigen (PSA)
* At least 2 consecutive rises in PSA levels, each taken ≥ 7 days apart
* PSA ≥ 5 ng/mL
* Must have pre-study PSA \> 5 ng/mL
* Measurable or evaluable disease
* Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
* Soft tissue disease that has been irradiated ≥ 2 months prior to study entry is considered measurable disease provided the lesion progressed after radiation
* Surgical or medical castration required
* If luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or LHRH antagonists (abarelix) were used, then must continue use during study therapy
* No prior or concurrent brain metastases (treated or untreated)
* If clinical suspicion of brain metastases, must meet the following criteria:
* Brain CT scan or MRI negative for metastatic disease within the past 56 days
* No new symptoms since radiographic evaluation
* Performance status - Zubrod 0-2
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Bilirubin normal
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 40 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Fertile patients must use effective contraception
* No peripheral neuropathy ≥ grade 2
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
* No other uncontrolled illness
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer in complete remission
* No colony-stimulating factors during the first course of study therapy
* No concurrent anticancer biologic therapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* See Disease Characteristics
* At least 4 weeks since prior flutamide or ketoconazole
* At least 6 weeks since prior bicalutamide or nilutamide
* No concurrent anticancer hormonal therapy except LHRH agonist or antagonist for patients who have not undergone orchiectomy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* Prior samarium Sm 153 lexidronam pentasodium allowed
* No prior strontium chloride Sr 89
* No prior radiotherapy to ≥ 30% of bone marrow
* No concurrent anticancer radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior surgery and recovered
* At least 2 weeks since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
* Clarithromycin
* Erythromycin
* Troleandomycin
* Rifampin
* Rifabutin
* Rifapentine
* Itraconazole
* Ketoconazole
* Fluconazole (dose \> 200 mg/day)
* Voriconazole
* Nefazodone
* Fluvoxamine
* Verapamil
* Diltiazem
* Grapefruit juice
* Bitter orange
* Phenytoin
* Carbamazepine
* Phenobarbital
* Oxcarbazepine
* Hypericum perforatum (St. John's wort)
* Modafinil
* At least 6 months since prior and no concurrent amiodarone
* No other investigational drugs for 4 weeks before, during, and for 2 weeks after study therapy
* No other concurrent anticancer cytotoxic therapy
* No other concurrent anticancer therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* Concurrent enrollment on SWOG-9205 (central prostate cancer serum repository protocol) allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.