Trial Outcomes & Findings for Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer (NCT NCT01026623)
NCT ID: NCT01026623
Last Updated: 2019-06-17
Results Overview
Defined as the time from the first day of treatment to the earliest one of the following: tumor progression by RECIST; unequivocal evidence of progression by bone scan (at least two new lesions with confirmation at subsequent imaging); new skeletal events; symptomatic progression; or other clinical events attributable to prostate cancer that necessitate major interventions. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 4 weeks after completion of study treatment
Results posted on
2019-06-17
Participant Flow
Participant milestones
| Measure |
IMC-A12: 6 mg/kg & Temsirolimus (CCI-779): 20 mg
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg & Temsirolimus (CCI-779): 25 mg
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg & Temsirolimus (CCI-779): 20 mg
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
IMC-A12: 6mg/kg Temsirolimus 20 mg
n=6 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after completion of study treatmentPopulation: All patients had withdrawn from study prior to data analysis. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report.
Defined as the time from the first day of treatment to the earliest one of the following: tumor progression by RECIST; unequivocal evidence of progression by bone scan (at least two new lesions with confirmation at subsequent imaging); new skeletal events; symptomatic progression; or other clinical events attributable to prostate cancer that necessitate major interventions. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 4 weeks after completion of study treatmentDefined by modified Response Evaluation Criteria in Solid Tumors (RECIST) and/or the proportion of patients who achieve a greater than 50% reduction in serum PSA compared to baseline.
Outcome measures
| Measure |
IMC-A12: 6 mg/kg Temsirolimus 20 mg
n=6 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Tumor Response Rate
Stable Disease
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Tumor Response Rate
Progression of Disease
|
4 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 1, Week 5, Week 9, Week 13, Week 17, Week 21 and Week 25Population: Outcome not calculated. PSA decline from baseline and imaging response (at twelve weeks) instead which are recognized PCWG3 endpoints for metastatic castration resistant disease was the outcome.
Compared using descriptive statistics. PSA doubling time is defined as the number of months it would take for PSA to increase two-fold. PSADT is inversely proportional to the slope of the regression line for the relation between log PSA and time. If this slope is negative, so the patient's PSA is going down over time, then the PSADT is negative.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time of first dose until the time of progression, assessed up to 4 weeks after completion of study treatmentSummarized using descriptive statistics.
Outcome measures
| Measure |
IMC-A12: 6 mg/kg Temsirolimus 20 mg
n=6 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Duration of Effect
|
35 weeks
Interval 10.0 to 60.0
|
17.5 weeks
Interval 12.0 to 36.0
|
16 weeks
Interval 4.0 to 22.0
|
SECONDARY outcome
Timeframe: From baseline to week 12Summarized using descriptive statistics (eg, mean, standard deviation, median, minimum, maximum). Maximum percent change in serum PSA (i.e., 100%\*\[(value at Week 12 minus value at baseline)/value at baseline\])
Outcome measures
| Measure |
IMC-A12: 6 mg/kg Temsirolimus 20 mg
n=6 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Maximal Percentage Change in Serum PSA as Compared to Week 12 Versus Baseline
|
8 percentage change in Serum PSA
Interval -47.0 to 63.0
|
-1 percentage change in Serum PSA
Interval -29.0 to 26.0
|
203 percentage change in Serum PSA
Interval 29.0 to 377.0
|
SECONDARY outcome
Timeframe: From the time of first dose until objective tumor progression or death, assessed up to 4 weeks after completion of study treatmentPopulation: All patients had withdrawn from study prior to data analysis.
Summarized using descriptive statistics. Median PFS over time will be determined using Kaplan Meier method. This Outcome Measure was related to the Phase 2 portion of the study, which did not occur. Therefore, there is no data to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks after completion of study treatmentAdverse event summaries will be organized by body system, frequency of occurrence, intensity (ie, severity grade), and causality or attribution. Please see Adverse Event/Serious Adverse Event Section.
Outcome measures
| Measure |
IMC-A12: 6 mg/kg Temsirolimus 20 mg
n=6 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 Participants
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Rate of Adverse Events According to NCI CTCAE Version 4.0
|
100 percentage of participants affected
|
100 percentage of participants affected
|
60 percentage of participants affected
|
Adverse Events
IMC-A12: 6mg/kg Temsirolimus 20 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
IMC-A12: 6 mg/kg Temsirolimus 25 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
IMC-A12: 20 mg/kg Temsirolimus 20 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMC-A12: 6mg/kg Temsirolimus 20 mg
n=6 participants at risk
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 participants at risk
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 participants at risk
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Investigations
Lipase increased
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
|
Investigations
Serum amylase increased
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/6
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
Other adverse events
| Measure |
IMC-A12: 6mg/kg Temsirolimus 20 mg
n=6 participants at risk
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly)
|
IMC-A12: 6 mg/kg Temsirolimus 25 mg
n=5 participants at risk
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly
|
IMC-A12: 20 mg/kg Temsirolimus 20 mg
n=5 participants at risk
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|---|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 2
|
20.0%
1/5 • Number of events 6
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Cholesterol high
|
0.00%
0/6
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2
|
40.0%
2/5 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
20.0%
1/5 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
4/6 • Number of events 36
|
60.0%
3/5 • Number of events 35
|
20.0%
1/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
33.3%
2/6 • Number of events 6
|
40.0%
2/5 • Number of events 4
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1
|
60.0%
3/5 • Number of events 5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6
|
20.0%
1/5 • Number of events 7
|
0.00%
0/5
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 3
|
0.00%
0/5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/6
|
20.0%
1/5 • Number of events 2
|
0.00%
0/5
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Tooth infection
|
16.7%
1/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60