Trial Outcomes & Findings for Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer (NCT NCT00529802)

Last Updated: 2018-04-25

Results Overview

The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-04-25

Participant Flow

A total of 60 patients started trial between December, 2007 and June, 2010 at 5 clinical sites. . A total of 63 patients signed consent, (1 withdrew consent, 2 failed screening)

This is a single-arm trial.

Participant milestones

Participant milestones
Measure	Everolimus All patients were to receive 10mg everolimus (RAD001) daily.
Evaluable for Primary Endpoint STARTED	60
Evaluable for Primary Endpoint COMPLETED	50
Evaluable for Primary Endpoint NOT COMPLETED	10
Evaluable for Secondary Endpoint STARTED	50
Evaluable for Secondary Endpoint COMPLETED	48
Evaluable for Secondary Endpoint NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Everolimus All patients were to receive 10mg everolimus (RAD001) daily.
Evaluable for Primary Endpoint Did not complete 2d CT scan	3
Evaluable for Primary Endpoint Worsening performance status	2
Evaluable for Primary Endpoint Adverse Event	2
Evaluable for Primary Endpoint Death	1
Evaluable for Primary Endpoint Lack of Efficacy	1
Evaluable for Primary Endpoint Lost to Follow-up	1
Evaluable for Secondary Endpoint Did not complete 2d FDG-PET scan	2

Baseline Characteristics

Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Everolimus n=50 Participants All patients were to receive 10mg everolimus (RAD001) daily.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Tumor Type Clear Cell	36 participants n=5 Participants
Tumor Type Papillary Cell	4 participants n=5 Participants
Tumor Type Chromophobe	4 participants n=5 Participants
Tumor Type Unclassified/Other	6 participants n=5 Participants
Average SUVmax Low Uptake (avgSUVmax<=4)	10 participants n=5 Participants
Average SUVmax High Uptake (avgSUVmax>4)	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 50 patients were evaluable for response and had a baseline FDG-PET scan.

Outcome measures

Outcome measures
Measure	Low Uptake n=10 Participants Low uptake FDG-PET is defined as avgSUVmax\<=4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the "standardized uptake value") .	High Uptake n=40 Participants High uptake of FDG-PET defined as avgSUVmax\>4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the "standardized uptake value") .
Relative Tumor Size Change Following 8 Weeks of Therapy.	1.4 Percent change from baseline Interval -31.7 to 17.3	-0.57 Percent change from baseline Interval -32.7 to 35.9

SECONDARY outcome

Timeframe: 2 weeks

Population: Patients evaluable for tumor response at 8 weeks who also had both the baseline and 2-week FDG-PET scans.

The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans.

Outcome measures

Outcome measures
Measure	Low Uptake n=48 Participants Low uptake FDG-PET is defined as avgSUVmax\<=4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the "standardized uptake value") .	High Uptake High uptake of FDG-PET defined as avgSUVmax\>4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the "standardized uptake value") .
Percent Change in FDG-PETUptake Following 2 Weeks of Therapy	-29.7 % change in avgSUVmax at 2 weeks Interval -75.3 to 0.0	—

Adverse Events

Everolimus

Serious events: 6 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Everolimus n=56 participants at risk All patients were to receive 10mg everolimus (RAD001) daily. These results are based on n=56 patients who were evaluable for toxicity.
Investigations Creatinine increased	1.8% 1/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Dyspnea	1.8% 1/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Fatigue	1.8% 1/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Injury, poisoning and procedural complications Fracture	1.8% 1/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.6% 2/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.8% 1/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).

Other adverse events

Other adverse events
Measure	Everolimus n=56 participants at risk All patients were to receive 10mg everolimus (RAD001) daily. These results are based on n=56 patients who were evaluable for toxicity.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify)	10.7% 6/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Gastrointestinal disorders Diarrhea	37.5% 21/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Nervous system disorders Dizziness	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Gastrointestinal disorders Dry mouth	7.1% 4/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Skin and subcutaneous tissue disorders Dry skin	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Dyspnea	33.9% 19/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Ear and labyrinth disorders Ear, nose and throat examination abnormal	44.6% 25/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Edema limbs	28.6% 16/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Fatigue	71.4% 40/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Fever	14.3% 8/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Gastrointestinal disorders Flatulence	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders General symptom	10.7% 6/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Nervous system disorders Headache	17.9% 10/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Investigations Hemoglobin decreased	41.1% 23/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Hemorrhage nasal	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Investigations Hypercholesterolemia	37.5% 21/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hyperglycemia	39.3% 22/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hyperkalemia	16.1% 9/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hypertriglyceridemia	42.9% 24/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hypoalbuminemia	16.1% 9/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hypocalcemia	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hyponatremia	16.1% 9/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Metabolism and nutrition disorders Hypophosphatemia	19.6% 11/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Psychiatric disorders Insomnia	10.7% 6/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Musculoskeletal and connective tissue disorders Joint pain	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Investigations Leukocytes	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Investigations Lymphopenia	10.7% 6/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Gastrointestinal disorders Mucositis oral	7.1% 4/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Skin and subcutaneous tissue disorders Nail changes	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Gastrointestinal disorders Nausea	37.5% 21/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Nervous system disorders Neurological disorder NOS	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Pain	14.3% 8/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Pain - Other	35.7% 20/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Musculoskeletal and connective tissue disorders Pain in extremity	10.7% 6/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Nervous system disorders Peripheral sensory neuropathy	7.1% 4/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Investigations Platelet count decreased	17.9% 10/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Pneumonitis	12.5% 7/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Skin and subcutaneous tissue disorders Pruritus	8.9% 5/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Respiratory, thoracic and mediastinal disorders Pulmonary - Other(specify)	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Skin and subcutaneous tissue disorders Rash	26.8% 15/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Skin and subcutaneous tissue disorders Rash desquamating	17.9% 10/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Rigors/chills	7.1% 4/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Cardiac disorders Sinus tachycardia	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
General disorders Taste alteration	14.3% 8/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Renal and urinary disorders Urinary frequency	7.1% 4/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Infections and infestations Urinary tract infection	5.4% 3/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Gastrointestinal disorders Vomiting	12.5% 7/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Investigations Weight loss	17.9% 10/56 These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).

Additional Information

Walter Stadler, MD

The University of Chicago

Phone: (773) 702-4150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60