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

NCT ID: NCT02128958

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2021-12-31

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.

Detailed Description

The trial will evaluate the efficacy and safety of CF102 as compared to placebo. Subjects will be randomly assigned in a 2:1 ratio to treatment with oral doses of either CF102 25 mg or matching placebo administered twice daily (BID) for consecutive, 28-day cycles. Subjects will be evaluated regularly for safety. Tumor imaging will be performed every 8 weeks. Treatment will continue until the subject experiences unacceptable drug-related intolerability. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug, and every attempt will be made to obtain survival data on all randomized subjects. Subjects who discontinue will be followed indefinitely for survival status. The trial will continue until 75 deaths have been recorded.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CF102

orally q12h

Group Type: EXPERIMENTAL

CF102

Intervention Type: DRUG

orally q12h

Placebo tablets of CF102

orally q12h

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

orally q12 hours

Interventions

CF102

orally q12h

Intervention Type: DRUG

Placebo

orally q12 hours

Intervention Type: DRUG

Other Intervention Names

IB-MECA; Inactive pill

Eligibility Criteria

Inclusion Criteria

1. Males and females at least 18 years of age.

2. 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).

3. HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.

4. 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).

5. Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit.

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).

7. Cirrhosis classified as Child-Pugh Class B (Appendix C).

8. 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.

9. Life expectancy of ≥ 6 weeks.

Exclusion Criteria

1. Receipt of no, or of >1, prior systemic drug therapies for HCC.

2. 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.

3. Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1, as determined by CTCAE v 4.0.

4. Locoregional treatment within 4 weeks prior to the Baseline Visit.

5. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.

6. Use of any investigational agent within 4 weeks prior to the Baseline Visit.

7. Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.

8. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.

9. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.

10. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.

11. Liver transplant.

12. Active malignancy other than HCC.

13. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).

14. 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.

15. 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.

16. Pregnant or lactating female.

17. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Can-Fite BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Silverman

Role: STUDY_DIRECTOR

Can-Fite BioPharma Ltd

Locations

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

Countries

United States; Bulgaria; Israel; Romania; Serbia

References

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.

Reference Type: BACKGROUND

PMID: 33430312 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CF102-201HCC

Identifier Type: -

Identifier Source: org_study_id