Trial Outcomes & Findings for PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer (NCT NCT00589550)
NCT ID: NCT00589550
Last Updated: 2015-06-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
1 participants
Primary outcome timeframe
up to 2 months
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Peginterferon Alfa-2b
Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
Withdrew From Study
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2b
n=1 Participants
Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis
|
|---|---|
|
Age, Customized
Age18-60
|
1 patient
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 2 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearOutcome measures
Outcome data not reported
Adverse Events
Peginterferon Alfa-2b
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Olencki, DO
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-2886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place