A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients W… (NCT01356628) | Clinical Trial Compass
CompletedPhase 2
A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer
United States23 participantsStarted 2011-05-25
Plain-language summary
This is a Phase 2 Study of PD-0332991 in the treatment of patients with Advanced Hepatocellular Carcinoma (HCC), a type of adenocarcinoma and the most common type of liver tumor. PD-0332991 is a compound that stops the tumor cell from entering the Synthesis phase of the cell cycle, therefore stopping DNA multiplication and decreased tumor cell copying.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, age \> or = 18 years with HCC refractory to currently available therapies.
✓. Documented HCC by at least 2 out of 3 mentioned criteria and evidence of non-resectability by a multidisciplinary team:
✓. Positive staining for RB-function on tumor biopsy.
✓. Subject must be able to give written informed consent and be able to follow protocol requirements
✓. Life expectancy greater than 3 months
✓. Be Child's-Pugh class A or B
✓. ECOG Performance status of \< or = 2
✓. If female of childbearing potential must have negative pregnancy test at screening and may not be breast-feeding
Exclusion criteria
✕. Any concurrent active malignancy requiring treatment (other than basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, or other malignancies curatively treated \> 3 years prior to study entry)
✕. History of severe cardiovascular disease within the last 12 months: symptomatic congestive heart failure, myocardial infarction, coronary artery disease (CAD), life threatening arrhythmias, uncontrolled hypertension
✕. Renal failure requiring hemo- or peritoneal dialysis
✕
What they're measuring
1
Time to Disease Progression
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Trial details
NCT IDNCT01356628
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University