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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02128958
Recruitment Status : Active, not recruiting
First Posted : May 1, 2014
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: CF102 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects With Child-Pugh Class B Cirrhosis
Study Start Date : September 2014
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: CF102
orally q12h
Drug: CF102
orally q12h
Other Name: IB-MECA

Placebo Comparator: Placebo tablets of CF102
orally q12h
Drug: Placebo
orally q12 hours
Other Name: Inactive pill




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 28-day cycles ]
    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.


Secondary Outcome Measures :
  1. time to progression [ Time Frame: 28-day cycles ]
    Evaluate other indicators of efficacy of CF102 as compared to placebo, including time to progression (TTP), progression-free survival (PFS), objective response (OR) rate, and disease control (DC) rate in this population;

  2. Safety profile [ Time Frame: 28-day cycles ]
    Characterize the safety profile of CF102 in subjects with advanced HCC and CPB cirrhosis;

  3. laboratory parameters of hepatic dysfunction and viral hepatitis [ Time Frame: 28-day cycles ]
    Characterize the effects of CF102 on laboratory parameters associated with viral hepatitis, hepatic dysfunction, and cirrhosis;

  4. adenosine A3 receptor (A3AR) expression [ Time Frame: 28-day cycles ]
    Explore the relationship between white blood cell (WBC) adenosine A3 receptor (A3AR) expression and clinical response.

  5. Pharmacokinetics (PK) of CF102 in this population [ Time Frame: Cycle 1 days 1, 8 and 15. Cycle 2 day 1 ]
    Explore exposure-response relationships using sparse pharmacokinetic (PK) sampling;



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128958


Locations
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United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Texas
Simmons Cancer Center
Dallas, Texas, United States, 75390
Bulgaria
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
Israel
Rabin Medical Center
Petach Tikva, Israel
Romania
Spitalul Pelican Impex SRL- Sectia Oncologie Medicala
Bihor, Romania
Institutul Clinic Fundeni - Sectia Oncologie Medicala
Bucuresti, Romania
Clinica Bendis - Oncologie Medicala
Cluj, Romania
Centrul de Oncologie ONCOLAB
Dolj, Romania
Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala
Iaşi, Romania
SC DACMED SRL - Oncologie
Prahova, Romania
Spitalului Clinic Judetean de Urgenta - Sectia Oncologie Medicala
Sibiu, Romania
Spitalul Judetean de Urgenta "Sf. Ioan Cel Nou" - sectia Oncologie Medicala
Suceava, Romania
Serbia
Vojnomedicinska Akademija Beograd
Belgrade, Serbia
Zdravstveni Centar Kladovo Služba Onkologije
Kladovo, Serbia
Klinički Centar Niš Klinika za Onkologiju
Niš, Serbia
Institut za Onkologiju Vojvodine
Sremska Kamenica, Serbia
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
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Study Director: Michael H Silverman Can-Fite BioPharma Ltd

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Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT02128958     History of Changes
Other Study ID Numbers: CF102-201HCC
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Can-Fite BioPharma:
Hepatocellular Carcinoma
Child-Pugh Class B Cirrhosis
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases