Trial · NCT02128958
Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
NCT02128958, Phase 2, Completed, Can-Fite BioPharma; results first posted 2021-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC). Trials, record NCT02128958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02128958
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
- NCT number
- NCT02128958
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- Can-Fite BioPharma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- CF102, Placebo
- First posted
- 2014-05-01
- Last updated
- 2022-10-04
- Results first posted
- 2021-12-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Overall Survival | From date of first treatment (Cycle 1 Day 1) until date of death from any cause, assessed up to 12 months | 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. |
| Secondary | 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 (TTP) is the time from Baseline to the first Overall Response of Progressive Disease (PD), calculated as date of first PD - date of Cycle 1 Day 1+1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. TTP will be summarized in months, which will be obtained by dividing TTP in days by 30 days/month. Summary statistics will be determined using the KM estimate of the survival function for TTP. The between-treatment comparison will be performed using the logrank test. |
| Secondary | 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 | Time to Progression-Free Survival (PFS) is the time from Baseline to the first Overall Response of Progressive Disease (PD) or death due to any cause if the subject dies without experiencing PD, calculated as date of first PD or date of death - date of Cycle 1 Day 1+1. PFS will be summarized in months, which will be obtained by dividing PFS in days by 30 days/month. Summary statistics will be determined using the KM estimate of the survival function for PFS. The between-treatment comparison will be performed using the logrank test. |
| Secondary | 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 | Objective Response Rate (ORR) is assessed as the percentage of subjects who achieved a Complete Response (CR) or Partial Response (PR). Per RECIST criteria v1.1, CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm; PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response is the sum of subjects achieving CR or PR. |
| Secondary | 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 | Disease Control Rate (DCR) is assessed as the percentage of subjects who achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) using RECIST criteria. Per RECIST criteria v1.1, CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm; PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm) taking as reference the smallest sum diameters while on study. |
| Secondary | Summary Statistics of Laboratory Parameters Associated With Viral Hepatitis, Hepatic Dysfunction, and Cirrhosis | Baseline (Cycle 1 Day 1); Cycle 11 Day 15 | The raw and change from baseline (CFB) for each laboratory parameter (alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin (direct and total), International Normalized Ratio (INR),and prothrombin time (PT)) will be summarized by treatment and visit. CFB is calculated as (Value at Post-Baseline visit - Value at Baseline). The baseline value used in the calculations of CFB is the value taken at Cycle 1 Day 1. |
| Secondary | Summary Statistics of White Blood Cell (WBC) Adenosine A3 Receptor (A3AR) Expression and Clinical Response - WBC Adenosine A3 Receptor (A3AR) Expression | Baseline (Cycle 1 Day 1) and Cycle 11 Day 1 | Summary statistics for WBC adenosine A3 receptor (A3AR) expression and CFB in WBC A3AR expression will be provided by treatment and visit. A3AR mRNA expression in WBC was determined from blood collected to a PAXgene RNA tubes (Qiagen, Venlo, The Netherlands), using the QuantiGene Plex 2.0® assay (Thermo Fisher, Waltham, MA, USA). β-actin was used as a reference control, and the oligonucleotide probe sets were designed by Thermo Fisher. Luminescence from each specific probe set was captured by Glomax Multi (Promega, Madison, WI, USA). A3AR was expressed in units, where 1 unit was defined as the mean of A3AR expression in healthy subjects (n = 50). Healthy subjects were 20-70 years of age with no known illness and no prior treatment. |
| Secondary | Pharmacokinetics (PK) Parameters of CF102 - CL/F (L/h) | Cycle 1 Days 1, 8 and 15; Cycle 2 day 1 | Describe the PK parameter CL/F (L/h) of namodenoson in subjects with Child-Pugh Class B cirrhosis who received twice daily administration of namodenoson for 29 days in Study CF102-201HCC at Day 1 and Day 29. In order to use a model-based Bayesian analysis in these subjects, a population PK (PPK) model of namodenoson had to be first created with the rich namodenoson concentration data available from two previously conducted studies (healthy volunteers in CF102-101 receiving single doses of 1 to 40 mg; and advanced hepatocellular carcinoma patients in CF102-102HCC receiving 1 to 25 mg BID of namodenoson for 29 days). |
| Secondary | Pharmacokinetics (PK) Parameters of CF102 - Vc/F (L) | Cycle 1 Days 1, 8 and 15; Cycle 2 day 1 | Describe the PK parameter Vc/F (L) of namodenoson in subjects with Child-Pugh Class B cirrhosis who received twice daily administration of namodenoson for 29 days in Study CF102-201HCC at Day 1 and Day 29. In order to use a model-based Bayesian analysis in these subjects, a population PK (PPK) model of namodenoson had to be first created with the rich namodenoson concentration data available from two previously conducted studies (healthy volunteers in CF102-101 receiving single doses of 1 to 40 mg; and advanced hepatocellular carcinoma patients in CF102-102HCC receiving 1 to 25 mg BID of namodenoson for 29 days). |
| Secondary | Pharmacokinetics (PK) Parameters of CF102 - Vp/F (L) | Cycle 1 Days 1, 8 and 15; Cycle 2 day 1 | Describe the PK parameter Vp/F (L) of namodenoson in subjects with Child-Pugh Class B cirrhosis who received twice daily administration of namodenoson for 29 days in Study CF102-201HCC at Day 1 and Day 29. In order to use a model-based Bayesian analysis in these subjects, a population PK (PPK) model of namodenoson had to be first created with the rich namodenoson concentration data available from two previously conducted studies (healthy volunteers in CF102-101 receiving single doses of 1 to 40 mg; and advanced hepatocellular carcinoma patients in CF102-102HCC receiving 1 to 25 mg BID of namodenoson for 29 days). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Overall Survival | From date of first treatment (Cycle 1 Day 1) until date of death from any cause, assessed up to 12 months | The analysis of the primary outcome measure was performed on the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | The analysis of the secondary outcome measure was performed on the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. | Months | MEDIAN |
| SECONDARY | 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 | The analysis of the secondary outcome measure was performed on the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. | months | MEDIAN |
| SECONDARY | 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 | The analysis of the secondary outcome measure was performed on the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | The analysis of the secondary outcome measure was performed on the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary Statistics of Laboratory Parameters Associated With Viral Hepatitis, Hepatic Dysfunction, and Cirrhosis | Baseline (Cycle 1 Day 1); Cycle 11 Day 15 | The analysis of the secondary outcome measure was performed on the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. | U/L | MEAN |
| SECONDARY | Summary Statistics of White Blood Cell (WBC) Adenosine A3 Receptor (A3AR) Expression and Clinical Response - WBC Adenosine A3 Receptor (A3AR) Expression | Baseline (Cycle 1 Day 1) and Cycle 11 Day 1 | The analysis of the secondary outcome measure was performed using data from selected study sites on subjects in the Intent-To-Treat (ITT) Population, defined as all subjects who received at least one dose of study medication (i.e., Safety Population) with any post-Baseline assessment recorded. Exclusion of subjects from the ITT Population was determined prior to unblinding. The selection of study sites for participation in the A3AR blood sampling was determined according to the protocol. | ratio of patient to healthy control | MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of CF102 - CL/F (L/h) | Cycle 1 Days 1, 8 and 15; Cycle 2 day 1 | The PK analysis was conducted on advanced hepatocellular carcinoma patients with Child Pugh class B cirrhosis who received 25 mg BID for 29 days. | L/h | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of CF102 - Vc/F (L) | Cycle 1 Days 1, 8 and 15; Cycle 2 day 1 | The PK analysis was conducted on advanced hepatocellular carcinoma patients with Child Pugh class B cirrhosis who received 25 mg BID for 29 days. | L | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of CF102 - Vp/F (L) | Cycle 1 Days 1, 8 and 15; Cycle 2 day 1 | The PK analysis was conducted on advanced hepatocellular carcinoma patients with Child Pugh class B cirrhosis who received 25 mg BID for 29 days. | L | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Overall Survival | CF102 | 12-month Survival - Yes | 16 | Participants | |
| Number of Subjects With Overall Survival | Placebo Tablets of CF102 | 12-month Survival - Yes | 4 | Participants | |
| Number of Subjects With Overall Survival | CF102 | 12-month Survival - No | 34 | Participants | |
| Number of Subjects With Overall Survival | Placebo Tablets of CF102 | 12-month Survival - No | 24 | Participants | |
| Time to Progression (TTP) | CF102 | 5.1 | Inter-Quartile Range 1.9 to 11.2 | Months | |
| Time to Progression (TTP) | Placebo Tablets of CF102 | 3.3 | Inter-Quartile Range 1.9 to 33.2 | Months | |
| Time to Progression-Free Survival (PFS) | CF102 | 2.5 | Inter-Quartile Range 1.8 to 6.1 | months | |
| Time to Progression-Free Survival (PFS) | Placebo Tablets of CF102 | 1.9 | Inter-Quartile Range 1.8 to 3.8 | months | |
| Objective Response Rate (ORR) | CF102 | Cycle 3 Day 1 | 1 | Participants | |
| Objective Response Rate (ORR) | Placebo Tablets of CF102 | Cycle 3 Day 1 | 0 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CF102 | 50 | |
| Overall Study | STARTED | Placebo Tablets of CF102 | 28 | |
| Overall Study | COMPLETED | CF102 | 29 | |
| Overall Study | COMPLETED | Placebo Tablets of CF102 | 18 | |
| Overall Study | NOT COMPLETED | CF102 | 21 | |
| Overall Study | NOT COMPLETED | Placebo Tablets of CF102 | 10 |
Source ClinicalTrials.gov
Adverse events158
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CF102 | 8 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Tablets of CF102 | 5 | 28 | |
| other | Abdominal Pain | Gastrointestinal disorders | CF102 | 9 | 50 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Tablets of CF102 | 3 | 28 | |
| other | Ascites | Gastrointestinal disorders | CF102 | 10 | 50 | |
| other | Ascites | Gastrointestinal disorders | Placebo Tablets of CF102 | 2 | 28 | |
| other | Constipation | Gastrointestinal disorders | CF102 | 0 | 50 | |
| other | Constipation | Gastrointestinal disorders | Placebo Tablets of CF102 | 2 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | CF102 | 2 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Tablets of CF102 | 2 | 28 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CF102 | 34 | 50 |
| Total, all-cause mortality | Placebo Tablets of CF102 | 24 | 28 |
| Total, other adverse events | CF102 | 46 | 50 |
| Total, other adverse events | Placebo Tablets of CF102 | 26 | 28 |
| Total, serious adverse events | CF102 | 37 | 50 |
| Total, serious adverse events | Placebo Tablets of CF102 | 20 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33430312 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CF102 vs Placebo Tablets of CF102: deaths from any cause | Trial comparisons |
| CF102 vs Placebo Tablets of CF102: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02128958
GET https://conductscience.org/api/trials/v1/NCT02128958/results?page=2