Clinical trial · Interventional
SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma
NCT00095992CI-TRIAL-00068562completedPhase 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)
RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ispinesib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response
- timeFrame
- 4 years
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- 4 years
- measure
- Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted)
- timeFrame
- 4 years
- measure
- Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs)
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed hepatocellular carcinoma
* Locally advanced, recurrent, or metastatic disease
* Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
* Measurable disease
* At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
* Outside of previously irradiated area
* Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
* Bone metastases are not considered measurable disease
* Not curable by standard therapies
* No cholangiocarcinoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 80,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 5 times ULN
* Must have hepatic reserve of Child-Turcotte-Pugh class A or better
Renal
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No active cardiomyopathy
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No clinical evidence of encephalopathy
* No ongoing or active infection
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered
* Documented disease progression
* No prior systemic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy
Surgery
* At least 4 weeks since prior major surgery
* Prior liver transplantation allowed
Other
* No other prior systemic therapy
* At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered
* Documented disease progression
* More than 28 days since prior investigational agents
* More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
* Clarithromycin
* Erythromycin
* Troleandomycin
* Itraconazole
* Ketoconazole
* Fluconazole (dose \> 200 mg/day)
* Voriconazole
* Nefazodone
* Fluvoxamine
* Verapamil
* Diltiazem
* Grapefruit juice
* Bitter orange
* Phenytoin
* Carbamazepine
* Phenobarbital
* Oxcarbazepine
* Rifampin
* Rifabutin
* Rifapentine
* Hypericum perforatum (St. John's wort)
* Modafinil
* At least 6 months since prior and no concurrent amiodarone
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
* No other concurrent investigational agentsReferences
Publications (1)
- RESULTKnox JJ, Gill S, Synold TW, Biagi JJ, Major P, Feld R, Cripps C, Wainman N, Eisenhauer E, Seymour L. A phase II and pharmacokinetic study of SB-715992, in patients with metastatic hepatocellular carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG IND.168). Invest New Drugs. 2008 Jun;26(3):265-72. doi: 10.1007/s10637-007-9103-2. Epub 2008 Jan 15. PMID 18196204