Trial Outcomes & Findings for A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED) (NCT NCT00800865)
NCT ID: NCT00800865
Last Updated: 2015-11-03
Results Overview
Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Baseline, 24, 32, and 48 hours post dose
Results posted on
2015-11-03
Participant Flow
There were 36 participants enrolled. Of these, 4 from Group I and 1 from Group II did not have evaluable biopsies and were considered not evaluable. Data only reflect the evaluable population (15 from Group I and 16 from Group II).
Participant milestones
| Measure |
Biomarker Evaluation Group I
Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
|
Biomarker Evaluation Group II
A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Biomarker Evaluation Group I
n=15 Participants
Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
|
Biomarker Evaluation Group II
n=16 Participants
A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
29-77 years
|
15 participants
n=5 Participants
|
0 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
34-88 years
|
0 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24, 32, and 48 hours post dosePopulation: Actual number of participants analyzed in Part I varied from 13 to 15, depending on time point. Actual number of participants analyzed in Part II was 16 for all time points.
Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Outcome measures
| Measure |
Biomarker Evaluation Group I
n=15 Participants
Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
|
Biomarker Evaluation Group II
n=16 Participants
A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
|
|---|---|---|
|
Level of Biomarkers
24 hours post chemotherapy
|
34.3 Percent pCDC2-positive cells
90% Confidence Interval 1.9 • Interval 25.6 to 46.0
|
23.0 Percent pCDC2-positive cells
90% Confidence Interval 1.9 • Interval 17.4 to 30.3
|
|
Level of Biomarkers
32 hours post chemotherapy
|
NA Percent pCDC2-positive cells
90% Confidence Interval NA
No samples taken at this time point in Part I
|
23.7 Percent pCDC2-positive cells
90% Confidence Interval 2.0 • Interval 17.5 to 32.1
|
|
Level of Biomarkers
48 hours post chemotherapy
|
50.3 Percent pCDC2-positive cells
90% Confidence Interval 1.7 • Interval 39.9 to 63.5
|
29.9 Percent pCDC2-positive cells
90% Confidence Interval 1.8 • Interval 23.2 to 38.6
|
|
Level of Biomarkers
Baseline
|
24.6 Percent pCDC2-positive cells
90% Confidence Interval 1.7 • Interval 19.0 to 31.8
|
NA Percent pCDC2-positive cells
90% Confidence Interval NA
Baseline value is not applicable in Part II
|
PRIMARY outcome
Timeframe: 24, 32, and 48 hours post doseRatio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.
Outcome measures
| Measure |
Biomarker Evaluation Group I
n=15 Participants
Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
|
Biomarker Evaluation Group II
n=16 Participants
A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
|
|---|---|---|
|
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
24 hours post chemotherapy/baseline
|
1.40 Ratio
90% Confidence Interval 1.59 • Interval 1.11 to 1.75
|
NA Ratio
90% Confidence Interval NA
Ratio not applicable for Part II
|
|
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
48 hours post chemotherapy/baseline
|
2.05 Ratio
90% Confidence Interval 1.78 • Interval 1.56 to 2.69
|
NA Ratio
90% Confidence Interval NA
Ratio not applicable for Part II
|
|
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
32 hours/24 hours post chemotherapy
|
NA Ratio
90% Confidence Interval NA
Ratio not applicable for Part I
|
1.03 Ratio
90% Confidence Interval 1.60 • Interval 0.84 to 1.27
|
|
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
48 hours/24 hours post chemotherapy
|
1.47 Ratio
90% Confidence Interval NA • Interval 1.12 to 1.91
|
1.30 Ratio
90% Confidence Interval 1.80 • Interval 1.01 to 1.69
|
|
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
48 hours/32 hours post chemotherapy
|
NA Ratio
90% Confidence Interval NA
Ratio not applicable for Part I
|
1.26 Ratio
90% Confidence Interval 1.75 • Interval 0.99 to 1.62
|
Adverse Events
Biomarker Evaluation Group I
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Biomarker Evaluation Group II
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biomarker Evaluation Group I
n=15 participants at risk
Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
|
Biomarker Evaluation Group II
n=16 participants at risk
A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
13.3%
2/15 • Number of events 2
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
6.7%
1/15 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
6.7%
1/15 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
6.7%
1/15 • Number of events 1
|
0.00%
0/16
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Number of events 1
|
12.5%
2/16 • Number of events 4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee This is an exploratory study to develop data for possible future studies. It is not intended to be published, unless important new information or data concerning the safety of a marketed product is obtained. The Sponsor must have the opportunity to review all abstracts, manuscripts, or presentations 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. Sponsor review can be expedited.
- Publication restrictions are in place
Restriction type: OTHER