Trial Outcomes & Findings for Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer (NCT NCT01599832)

Last Updated: 2017-06-08

Results Overview

Specifically, whether the change in K\^trans (the rise from nadir) as a time-dependent covariate, as assessed by the method described in Donner, is associated with disease progression.Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)

Recruitment status

TERMINATED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

2 years

Results posted on

2017-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) n=20 Participants Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Age, Continuous	63 years n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Race/Ethnicity, Customized White	13 Participants n=99 Participants
Race/Ethnicity, Customized African American	2 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=99 Participants
Race/Ethnicity, Customized Not reported	3 Participants n=99 Participants
Region of Enrollment United States	20 Participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The accrued sample size of n=20 did not permit further assessment (as described in the Outcome Measure Description) of the primary endpoint, so simply reporting the median progression-free survival here

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) n=20 Participants Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Disease Progression	32.1 weeks Interval 7.6 to 79.6

SECONDARY outcome

Timeframe: Baseline and 1, 8, 16, and 24 weeks post-treatment

Population: Included those with a baseline K\^Trans value and at least 1 K\^trans value at follow-up

K\^trans is a derived measure from dynamic contrast-enhanced magnetic resonance imaging that reflects perfusion rate and capillary permeability. The change is reported as the log-transformed ratio of K\^trans value at follow-up/baseline.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) n=17 Participants Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Change in K^Trans From Baseline week 1	-0.680 unitless [log(ratio)] Standard Deviation 0.729
Change in K^Trans From Baseline week 8	-1.049 unitless [log(ratio)] Standard Deviation 0.634
Change in K^Trans From Baseline week 16	-0.998 unitless [log(ratio)] Standard Deviation 0.757
Change in K^Trans From Baseline week 24	-0.755 unitless [log(ratio)] Standard Deviation 0.952

SECONDARY outcome

Timeframe: Baseline and 1 week post-treatment

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 1 week post-treatment

Population: Data not collected

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Included those with a baseline K\^trans value

Specifically, whether baseline K\^trans is associated with progression-free survival. Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) n=18 Participants Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Progression-free Survival	32.1 weeks Interval 7.6 to 79.6

Adverse Events

Treatment (Pazopanib Hydrochloride, DCE-MRI)

Serious events: 8 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) n=20 participants at risk Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Respiratory, thoracic and mediastinal disorders Pneumonia	5.0% 1/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Vascular disorders Hypertension	5.0% 1/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Diarrhea	5.0% 1/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Musculoskeletal and connective tissue disorders Muscle Weakness lower limb	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
General disorders Pain	5.0% 1/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Alanine aminotransferase increased	5.0% 1/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.

Other adverse events

Other adverse events
Measure	Treatment (Pazopanib Hydrochloride, DCE-MRI) n=20 participants at risk Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7. pazopanib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging pharmacogenomic studies: Correlative studies
Investigations Alanine aminotransferase increased	20.0% 4/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Alkaline phosphatase increased	20.0% 4/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Blood and lymphatic system disorders Anemia	30.0% 6/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Metabolism and nutrition disorders Anorexia	55.0% 11/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Aspartate aminotransferase increased	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Blood bilirubin increased	25.0% 5/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Constipation	35.0% 7/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Diarrhea	65.0% 13/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Nervous system disorders Dysgeusia	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
General disorders Fatigue	65.0% 13/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Nervous system disorders Headache	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Vascular disorders Hypertension	30.0% 6/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Metabolism and nutrition disorders Hypoalbuminemia	30.0% 6/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Metabolism and nutrition disorders Hyponatremia	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Metabolism and nutrition disorders Hypophosphatemia	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Mucositis oral	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Nausea	55.0% 11/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Renal and urinary disorders Proteinuria	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Vomiting	35.0% 7/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Metabolism and nutrition disorders Hypercalcemia	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Nervous system disorders Dizziness	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Weight loss	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Creatinine increased	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations Platelet count decreased	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Renal and urinary disorders chronic kidney disease	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Renal and urinary disorders Hematuria	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Metabolism and nutrition disorders Hypoglycemia	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Investigations White blood cell decreased	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Gastrointestinal disorders Abdominal pain	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
General disorders Non-cardiac chest pain	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
General disorders Pain	15.0% 3/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.
Skin and subcutaneous tissue disorders Hair color change	10.0% 2/20 All serious adverse events are reported. For other adverse events, those that occurred in \>5% of patients are reported.

Additional Information

Walter Stadler

University of Chicago Comprehensive Cancer Center

Phone: (773) 702-4150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place