Trial Outcomes & Findings for Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215) (NCT NCT01521780)
NCT ID: NCT01521780
Last Updated: 2015-11-02
Results Overview
Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
TERMINATED
PHASE1
12 participants
Visit 3, approximately 7 days after screening Visit 1.
2015-11-02
Participant Flow
Participant milestones
| Measure |
Imaging
Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor.
|
Pathology
Pathology samples from surgical resection of HCC tumor and adjacent liver.
|
Imaging/Pathology
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
1
|
2
|
|
Overall Study
COMPLETED
|
9
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
Participants who enrolled in the study
|
|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 14.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3, approximately 7 days after screening Visit 1.Population: Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit 3, approximately 7 days after screening Visit 1.Population: Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 2, approximately 7 days after screening Visit 1.Population: Eleven participants underwent MRI and DW MRI scans and only ten of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.
Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to determine the volume of each tumor. The mean of log tumor volume is presented, based on tumors as observation units.
Outcome measures
| Measure |
Imaging
n=10 Tumors
Magnetic resonance imaging (MRI) of HCC tumor.
|
Pathology
Pathology samples from surgical resection of HCC tumor and adjacent liver.
|
Imaging/Pathology
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
|
|---|---|---|---|
|
Tumor Volumes From Repeated MRI Measurements of HCC.
|
3.38 log cm^3
Standard Deviation 0.235
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 2, approximately 7 days after screening Visit 1.Population: Eleven participants underwent MRI and DW MRI scans and only eight of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.
Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to derive a Median ADC for each tumor. The mean of the Median ADCs is presented based on tumours as observation units.
Outcome measures
| Measure |
Imaging
n=8 Tumors
Magnetic resonance imaging (MRI) of HCC tumor.
|
Pathology
Pathology samples from surgical resection of HCC tumor and adjacent liver.
|
Imaging/Pathology
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
|
|---|---|---|---|
|
Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.
|
1340.56 um^2/s
Standard Deviation 64.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 3, approximately 7 days after screening Visit 1.Population: Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin mRNA by qRT-PCR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 3, approximately 7 days after screening Visit 1.Population: Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 3, approximately 7 days after screening Visit 1.Population: Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Resected tumors and adjacent tissues were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for LDL-R protein by automated image analysis.
Outcome measures
Outcome data not reported
Adverse Events
Imaging
Pathology
Imaging/Pathology
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER