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Hepatocellular CarcinomaPhase 1/2NCT00790218

A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma

A Phase 1/2 study testing CF102 in people with Hepatocellular Carcinoma, run by Can-Fite BioPharma at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer. Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily basis. Treatment will be assessed for adverse effects and for effects on the tumor. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
CF102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteIsrael
Study dates
Feb 2009to Dec 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of HCC:
  • For patients without underlying cirrhosis, diagnosis of HCC documented by cytology and/or histology
  • For patients with underlying cirrhosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix V).
  • HCC is advanced, refractory, or metastatic, and no standard therapies are expected to be curative.
  • At least 18 years of age.
  • For subjects in the dose-confirmation (RP2D) phase only: Measurable disease, using Response Evaluation Criteria in Solid Tumors (RECIST, Appendix IV). (Note that a lesion that has been subjected to radiotherapy or chemoembolization cannot be used as a target lesion.)
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  • Eastern Collaborative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at baseline.
  • The following laboratory values must be documented within 3 days prior to initiation of study drug:
  • Absolute neutrophil count (ANC) greater than or equal to 1 x 109/L
  • Platelet count greater than or equal to 50 x 109/L
  • Serum creatinine less than or equal to 2.0 mg/dL
  • Aspartic aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal.
  • Total bilirubin ≤ 3.0 mg/dL.
  • Serum albumin ≥ 3.0 g/dL.
  • International normalized ratio (INR) ≤ 2.3.
  • Esophageal bleeding and varices, if present, have been sclerosed or banded, and no bleeding episodes have occurred during the prior 6 months.
  • Life expectancy of ≥ 12 weeks.
  • For women of childbearing potential, negative serum pregnancy test result.
  • Absence of active malignancy other than HCC within 2 years of entry, with the exception of basal cell carcinoma and squamous cell carcinoma of the skin.
  • Provide written informed consent to participate.
  • Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study related procedures.
  • -

Who cannot join

  • Any chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, corticosteroids > 20 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug.
  • Major surgery or radiation therapy within 28 days prior to initiation of study drug.
  • Severe liver dysfunction (Child-Pugh Class C or hepatic encephalopathy).
  • Active infection requiring systemic therapy.
  • Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), 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.
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  • Pregnant or lactating female.
  • Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Principal Investigator (PI), are effective and adequate for that patient's circumstances while on study drug.
  • Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug.
  • Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
  • Any severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.
  • -

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Rabin Medical Center

    Tel Aviv

Other trials in Israel

About this study

Official title: A Phase 1-2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered CF102 in Patients With Advanced Hepatocellular Carcinoma

This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer. Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily basis. Treatment will be assessed for adverse effects and for effects on the tumor.

Read the detailed description

This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in 2 phases: a dose-escalation phase, to determine the MTD of CF102 and to evaluate its safety/tolerability, PK, pharmacodynamic, and preliminary clinical activity; and a dose-confirmation phase, which will be a cohort expansion at or below the MTD (ie, the RP2D) of CF102. Subjects will be treated with oral doses of CF102 in consecutive, 28-day cycles. The initial dose of CF102 will be 1 mg twice daily (BID), with subsequent escalations to 5 and 25 mg BID, unless limited by toxicity. Subjects will be evaluated weekly for the first cycle, every 2 weeks for Cycles 2 and 3, and at the end of each subsequent cycle, up to 6 cycles of CF102 treatment. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug.

Being tested
CF102
Keywords
Hepatocellular carcinoma, Hepatoma, HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF102Drug

    Also called 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide, Cl-IB-MECA

    CF102 capsules twice daily by mouth

Study groups in NCT00790218
Study groupRoleWhat they receive
CF102 1mgExperimentalAn open-label trial in 28-day cycles.
Receives: Drug: CF102
CF102 5mgExperimentalAn open-label trial in 28-day cycles.
Receives: Drug: CF102
CF102 25mgExperimentalAn open-label trial in 28-day cycles.
Receives: Drug: CF102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity

    Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1

    Measured: From start of treatment until Day 28 of Cycle 1

  2. Maximum Tolerated Dose

    The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.

    Measured: first 28 days (Cycle 1)

  3. Maximum Plasma Concentration of CF102 (Cmax)

    Blood samples were collected and plasma concentrations determined using a high-pressure liquid chromatography method.

    Measured: Dose Escalation Phase on Day 1 and Day 29 pre-dose and at 1, 2, 3, 4, 6, 8 hours post-dose

Secondary outcomes (2)

  1. Number of Subjects With Objective Tumor Response

    Therapeutic effect of CF102 in hepatocellular carcinoma measured by number of subjects with objective tumor response

    Measured: 6 months

  2. Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102

    The Peripheral Blood Mononuclear Cells (PBMC) were to be collected at Baseline and Day 28 in order to evaluate the Adenosine A3 receptor (A3AR) and PBMC biomarkers, and clinical effects of CF102.

    Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Study Arms: CF102 (1, 5, and 25 mg BID) in 28-day cycles.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790218
Sponsor's protocol ID
CF102-102HCC
Status last verified
Apr 2022
First submitted
11 Nov 2008
Last updated
17 May 2022
Data monitoring committee
Yes

Publications

  • Bar-Yehuda S, Stemmer SM, Madi L, Castel D, Ochaion A, Cohen S, Barer F, Zabutti A, Perez-Liz G, Del Valle L, Fishman P. The A3 adenosine receptor agonist CF102 induces apoptosis of hepatocellular carcinoma via de-regulation of the Wnt and NF-kappaB signal transduction pathways. Int J Oncol. 2008 Aug;33(2):287-95.

    PubMed 18636149

  • Stemmer SM, Benjaminov O, Medalia G, Ciuraru NB, Silverman MH, Bar-Yehuda S, Fishman S, Harpaz Z, Farbstein M, Cohen S, Patoka R, Singer B, Kerns WD, Fishman P. CF102 for the treatment of hepatocellular carcinoma: a phase I/II, open-label, dose-escalation study. Oncologist. 2013;18(1):25-6. doi: 10.1634/theoncologist.2012-0211. Epub 2013 Jan 8.

    PubMed 23299770

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CF102 in people with Hepatocellular Carcinoma, run by Can-Fite BioPharma at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (time frame: From start of treatment until Day 28 of Cycle 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790218, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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