Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1 prior systemic drug therapy for HCC.

Key facts

Study ID: NCT02128958
Run by: Can-Fite BioPharma
People needed: 78
Starts: 2014-09-01
Expected to finish: 2021-12-31
Last updated by the study team: 2022-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males and females at least 18 years of age.
Diagnosis of HCC:
For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology.
For subjects with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix E).
HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.
Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).
Cirrhosis classified as Child-Pugh Class B (Appendix C).
The following laboratory values must be documented within 3 days prior to the first dose of study drug:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Platelet count ≥ 75 × 109/L
Serum creatinine ≤ 2.0 mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of normal (ULN)
Total bilirubin ≤ 3.0 mg/dL
Serum albumin ≥ 2.8 g/dL
Prothrombin time (PT) no greater than 6 seconds longer than control.
Life expectancy of ≥ 6 weeks.

You may not qualify if…

Receipt of no, or of >1, prior systemic drug therapies for HCC.
Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1, as determined by CTCAE v 4.0.
Locoregional treatment within 4 weeks prior to the Baseline Visit.
Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
Use of any investigational agent within 4 weeks prior to the Baseline Visit.
Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
Liver transplant.
Active malignancy other than HCC.
Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
Pregnant or lactating female.
Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the subject inappropriate for entry into this trial.

Where it is running

University of Colorado Cancer Center — Aurora, Colorado, United States
Simmons Cancer Center — Dallas, Texas, United States
Complex Oncology Center - Plovdiv — Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospita — Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment "Tokuda Hospital Sofia" AD — Sofia, Bulgaria
Multiprofile Hospital for Active Treatment for women's health - Nadezhda — Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Serdica — Sofia, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina" EAD — Varna, Bulgaria
Rabin Medical Center — Petah Tikva, Israel
Institutul Clinic Fundeni - Sectia Oncologie Medicala — Bucharest, Romania
Clinica Bendis - Oncologie Medicala — Cluj-Napoca, Romania
Centrul de Oncologie ONCOLAB — Craiova, Romania
Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala — Iași, Romania
Spitalul Pelican Impex SRL- Sectia Oncologie Medicala — Oradea, Romania
SC DACMED SRL - Oncologie — Ploieşti, Romania
Spitalului Clinic Judetean de Urgenta - Sectia Oncologie Medicala — Sibiu, Romania
Spitalul Judetean de Urgenta "Sf. Ioan Cel Nou" - sectia Oncologie Medicala — Suceava, Romania
Vojnomedicinska Akademija Beograd — Belgrade, Serbia
Institut za Onkologiju Vojvodine — Kamenitz, Serbia
Zdravstveni Centar Kladovo Služba Onkologije — Kladovo, Serbia
Klinički Centar Niš Klinika za Onkologiju — Niš, Serbia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.