Trial · NCT02128958
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | Pharmacokinetics (PK) Parameters of CF102 - Vss/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 - Elimination Half-life (Hours) | 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. | hours | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK) Parameters of CF102 - AUC_0-12, Steady State (ng*h/mL) | 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. | ng*h/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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