Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Who can join
18 and older, any sex, with Advanced Hepatocellular Carcinoma or HCC. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Disease ProgressionPrimary· 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
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST Version 1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.
Group
Value
95% CI
PD-0332991
8
3 – 8
Number of Adverse EventsSecondary· From date of randomization through study completion, assessed up to 100 months
The number and nature of adverse events as a measure of safety and tolerability. Safety analysis will be conducted on all patients who receive at least one dose of PD-0332991 during the study period or follow-up. An adverse event is any unfavorable and unintended sign, symptom, syndrome or illness that develops during the period of observation in the clinical study, including a new illness or condition, worsening of a concomitant illnesses or condition, effect of the study medication or combination of 2 or more factors.
Group
Value
95% CI
PD-0332991
504
Overall Survival (OS)Secondary· Every 2 weeks during first 3 cycles, then monthly during treatment. Then Day 28, Day 56 and every 3 months from last administration of protocol directed therapy or death
Overall survival (OS) is measured from the entry onto the trial until death of any cause. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer-unrelated.
Group
Value
95% CI
PD-0332991
40
24 – 96
Response Rate (RR)Secondary· Every 8 weeks
The best overall response is the best response recorded from the start of treatment until disease progression or recurrence. The objective response rate is the proportion of subjects with either a confirmed complete response (CR) or a confirmed partial response (PR) as determined using modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Subjects with the response of stable disease (SD) will be recorded and documented. Disease control rate defined as CR+PR+SD will be calculated for all subjects treated with PD-0332991.
Group
Value
95% CI
PD-0332991
1
PD-0332991
0
PD-0332991
7
PD-0332991
11
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01740427 — A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HE
· Phase 3
· completed
NCT01684215 — A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid T
· Phase 2
· completed
Other recruiting trials for Advanced Hepatocellular Carcinoma
Currently open trials in the same condition.
NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-
· Phase 3
· recruiting
NCT07174570 — Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer
· Phase 2
· recruiting
NCT07227012 — Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatmen
· Phase 1, PHASE2
· recruiting
NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta
· Phase 1, PHASE2
· recruiting
NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers
· Phase 2
· recruiting
Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials
Trials by the same sponsor.
NCT06974981 — Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
· recruiting
NCT03796884 — Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
· Phase 2
· active not recruiting
NCT03712904 — Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
· Phase 2
· terminated
NCT03807492 — Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
· completed
NCT03477864 — Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progres
· Phase 1
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Last refreshed: 28 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01356628.