Trial Outcomes & Findings for Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response (NCT NCT00694096)

Last Updated: 2015-12-01

Results Overview

Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) \< 25% change in SUVmax.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

4 weeks

Results posted on

2015-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 - Sunitinib 37.5 mg Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 - Sunitinib 37.5 mg Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 - Sunitinib 37.5 mg n=25 Participants Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.

Outcome measures

Outcome measures
Measure	Arm 1 - Sunitinib 37.5 mg n=19 Participants Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Metabolic Response	5 participants

PRIMARY outcome

Timeframe: 4 weeks

Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) \< 25% change in SUVmax.

Outcome measures

Outcome measures
Measure	Arm 1 - Sunitinib 37.5 mg n=19 Participants Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Proliferative Response	9 participants

SECONDARY outcome

Timeframe: 2399 days

Population: All patients that received study treatment and PET scans at baseline and follow-up

The length of time from the start of treatment for a disease that patients are still alive; no time limit was imposed on data collection

Outcome measures

Outcome measures
Measure	Arm 1 - Sunitinib 37.5 mg n=20 Participants Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Overall Survival	667.5 days Interval 27.0 to 2399.0

Adverse Events

Arm 1 - Sunitinib 37.5 mg

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 - Sunitinib 37.5 mg n=25 participants at risk Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Nervous system disorders Syncope	4.0% 1/25
Renal and urinary disorders Infection: Urinary Tract	4.0% 1/25
Gastrointestinal disorders Dehydration	4.0% 1/25
Gastrointestinal disorders Obstruction: Bowel	4.0% 1/25
General disorders Death	4.0% 1/25
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity Lower	4.0% 1/25

Other adverse events

Other adverse events
Measure	Arm 1 - Sunitinib 37.5 mg n=25 participants at risk Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
Metabolism and nutrition disorders Alkaline Phosphatase: Increased	8.0% 2/25 • Number of events 2
Metabolism and nutrition disorders ALT Increase	8.0% 2/25 • Number of events 3
Gastrointestinal disorders Anorexia	12.0% 3/25 • Number of events 3
Metabolism and nutrition disorders AST Increase	16.0% 4/25 • Number of events 4
Gastrointestinal disorders Constipation	8.0% 2/25 • Number of events 2
Metabolism and nutrition disorders Creatinine Increased	24.0% 6/25 • Number of events 7
Gastrointestinal disorders Diarrhea	16.0% 4/25 • Number of events 4
Nervous system disorders Dizziness	8.0% 2/25 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	8.0% 2/25 • Number of events 2
General disorders Fatigue	24.0% 6/25 • Number of events 7
Metabolism and nutrition disorders Glutamyl transpeptidase: increase	12.0% 3/25 • Number of events 3
Blood and lymphatic system disorders Hemoglobin: decrease	16.0% 4/25 • Number of events 4
Metabolism and nutrition disorders Hyperglycemia	12.0% 3/25 • Number of events 3
Metabolism and nutrition disorders Hyperkalemia	8.0% 2/25 • Number of events 2
Metabolism and nutrition disorders Hypoalbuminemia	8.0% 2/25 • Number of events 3
Metabolism and nutrition disorders Hyponatremia	12.0% 3/25 • Number of events 4
Renal and urinary disorders Infection: Urinary Tract	8.0% 2/25 • Number of events 2
Blood and lymphatic system disorders Leukocytes: decrease	8.0% 2/25 • Number of events 2
Blood and lymphatic system disorders Lymphopenia	12.0% 3/25 • Number of events 4
Gastrointestinal disorders Nausea	32.0% 8/25 • Number of events 8
Gastrointestinal disorders Obstruction: bowel	8.0% 2/25 • Number of events 2
Gastrointestinal disorders Pain: Oral Cavity	8.0% 2/25 • Number of events 2
Blood and lymphatic system disorders Partial Thromboplastin Time increase	16.0% 4/25 • Number of events 4
Blood and lymphatic system disorders Platelets: decrease	28.0% 7/25 • Number of events 8
Skin and subcutaneous tissue disorders Pruritus	8.0% 2/25 • Number of events 2
Gastrointestinal disorders Vomiting	16.0% 4/25 • Number of events 4

Additional Information

Mark Wade, Ph.D. - Compliance Officer

Huntsman Cancer Institute

Phone: 801-213-5746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place