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

NCT02128958 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CF102-201HCC
• Study Type: interventional
• Target: 78
• Locations: 5 countries
• Sites: 21

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Child-Pugh Class B Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Overall Survival

  Evaluate the efficacy of orally administered CF102 25 mg twice daily (BID) as compared to placebo, as determined by Overall Survival (OS), when used as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B (CPB) cirrhosis. Overall Survival is defined as the time from Baseline (Cycle 1 Day 1) to death due to any cause, calculated as (date of death- date of Cycle 1 Day 1) +1.OS will be summarized in months, which will be obtained by dividing OS in days by 30 days/month. Summary statistics will be determined using the Kaplan-Meier (KM) estimate of the survival function and the between-treatment comparison will be performed using the logrank test as the primary analysis.

  From date of first treatment (Cycle 1 Day 1) until date of death from any cause, assessed up to 12 months

Secondary Outcomes (12)

• Time to Progression (TTP)

  From date of first treatment (Cycle 1 Day 1) until the date of first documented progression, assessed up to 36 months

• Time to Progression-Free Survival (PFS)

  From date of first treatment (Cycle 1 Day 1) until the date of first documented disease progression or date of death, which occurred first, assessed up to 36 months

• Objective Response Rate (ORR)

  The end of even-numbered cycles (Cycle 3 Day 1,Cycle 5 Day 1,Cycle 7 Day 1, Cycle 9 Day 1, Cycle 11 Day 1) assessed up to 12 months

• Disease Control Rate (DCR)

  The end of even-numbered cycles (Cycle 3 Day 1,Cycle 5 Day 1,Cycle 7 Day 1, Cycle 9 Day 1, Cycle 11 Day 1) assessed up to 12 months

• Summary Statistics of Laboratory Parameters Associated With Viral Hepatitis, Hepatic Dysfunction, and Cirrhosis

  Baseline (Cycle 1 Day 1); Cycle 11 Day 15

Study Arms (2)

CF102

EXPERIMENTAL

orally q12h

Drug: CF102

Placebo tablets of CF102

PLACEBO COMPARATOR

orally q12h

Drug: Placebo

Interventions

CF102 DRUG

orally q12h

Also known as: IB-MECA

CF102

Placebo DRUG

orally q12 hours

Also known as: Inactive pill

Placebo tablets of CF102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

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.

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (21)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Simmons Cancer Center

Dallas, Texas, 75390, United States

Location

Complex Oncology Center - Plovdiv

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment Central Onco Hospita

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Tokuda Hospital Sofia" AD

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment for women's health - Nadezhda

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment Serdica

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sveta Marina" EAD

Varna, Bulgaria

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Institutul Clinic Fundeni - Sectia Oncologie Medicala

Bucharest, Romania

Location

Clinica Bendis - Oncologie Medicala

Cluj-Napoca, Romania

Location

Centrul de Oncologie ONCOLAB

Craiova, Romania

Location

Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala

Iași, Romania

Location

Spitalul Pelican Impex SRL- Sectia Oncologie Medicala

Oradea, Romania

Location

SC DACMED SRL - Oncologie

Ploieşti, Romania

Location

Spitalului Clinic Judetean de Urgenta - Sectia Oncologie Medicala

Sibiu, Romania

Location

Spitalul Judetean de Urgenta "Sf. Ioan Cel Nou" - sectia Oncologie Medicala

Suceava, Romania

Location

Vojnomedicinska Akademija Beograd

Belgrade, Serbia

Location

Institut za Onkologiju Vojvodine

Kamenitz, Serbia

Location

Zdravstveni Centar Kladovo Služba Onkologije

Kladovo, Serbia

Location

Klinički Centar Niš Klinika za Onkologiju

Niš, Serbia

Location

Related Publications (1)

• Stemmer SM, Manojlovic NS, Marinca MV, Petrov P, Cherciu N, Ganea D, Ciuleanu TE, Pusca IA, Beg MS, Purcell WT, Croitoru AE, Ilieva RN, Natosevic S, Nita AL, Kalev DN, Harpaz Z, Farbstein M, Silverman MH, Bristol D, Itzhak I, Fishman P. Namodenoson in Advanced Hepatocellular Carcinoma and Child-Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial. Cancers (Basel). 2021 Jan 7;13(2):187. doi: 10.3390/cancers13020187.

  PMID: 33430312 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Pnina Fishman, PhD, CEO
• Organization: Can-Fite BioPharma

pnina@canfite.co.il

972-3-924-1114

Study Officials

• Michael H Silverman

  Can-Fite BioPharma Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: May 1, 2014
• Study Start: September 1, 2014
• Primary Completion: November 27, 2017
• Study Completion: December 31, 2021
• Last Updated: October 4, 2022
• Results First Posted: December 29, 2021

Record last verified: 2022-09

Locations

BU (6); SE (4); RO (8); US (2); IL (1)