Trial Outcomes & Findings for Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer (NCT NCT00331409)

NCT ID: NCT00331409

Last Updated: 2017-10-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 3 months post 1st dose
• Results posted on: 2017-10-26

Participant Flow

Initial recruitment began in Feb 2006 and ended in Dec 2007. 19 patients were put on study during that time frame. These patients came from OHSU oncology clinics or referrals to OHSU.

During the first stage, patients not assessable for progression-free status at 3 months due to study discontinuation for any reason except death or progression were replaced only for purposes of determining continuation to the second stage.A total of 19 patients were enrolled in the first stage 15 evaluable patients and 4 patients who were not.

Participant milestones

Measure	Everolimus and Imatinib Mesylate Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Everolimus and Imatinib Mesylate Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Overall Study Lack of Efficacy	4

Baseline Characteristics

Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

Baseline characteristics by cohort

Measure	Everolimus and Imatinib Mesylate n=19 Participants Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants
Age, Continuous	65 years STANDARD_DEVIATION 7.7459 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Region of Enrollment United States	19 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months post 1st dose

Outcome measures

Measure	Everolimus and Imatinib Mesylate n=19 Participants Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Progression-free Survival at 3 Months	2.9 months Interval 1.9 to 6.2

PRIMARY outcome

Timeframe: Up to 4 years

Outcome measures

Measure	Everolimus and Imatinib Mesylate n=19 Participants Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months	18 participants

SECONDARY outcome

Timeframe: Time to progression

Outcome measures

Measure	Everolimus and Imatinib Mesylate n=19 Participants Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Median Time to Progression	2.9 months Interval 1.9 to 6.2

SECONDARY outcome

Timeframe: Up to 4 years

Population: 2 subjects were not evaluable. Reduction in target lesion sum did not meet the criteria for Partial Response (PR) for any of the subjects. Partial Response, per RECIST, includes at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Outcome measures

Measure	Everolimus and Imatinib Mesylate n=17 Participants Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Number of Subjects That Demonstrated a Reduction in Tumor Measurements.	5 Participants

SECONDARY outcome

Timeframe: Duration of study, Up to 4 years

Toxicity assessments will be obtained as follows:

Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles

Safety assessments will consist of evaluating adverse events and serious adverse events.

Outcome measures

Measure	Everolimus and Imatinib Mesylate n=19 Participants Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Number of Participants With Adverse Events	19 participants

Adverse Events

Everolimus and Imatinib Mesylate

Serious events: 10 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Everolimus and Imatinib Mesylate n=19 participants at risk Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Blood and lymphatic system disorders Anemia	21.1% 4/19 • Number of events 4
Skin and subcutaneous tissue disorders Rash	5.3% 1/19
Respiratory, thoracic and mediastinal disorders Pleural Effusions	15.8% 3/19
Infections and infestations Pneumonitis	5.3% 1/19
General disorders Fatigue	10.5% 2/19
Blood and lymphatic system disorders Angioedema Tongue	5.3% 1/19
Gastrointestinal disorders Diarrhea	5.3% 1/19
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 1/19
Vascular disorders Syncope	5.3% 1/19
Cardiac disorders Hypotension	5.3% 1/19
Renal and urinary disorders Renal Failure	5.3% 1/19
Infections and infestations Urinary Tract Infrection	5.3% 1/19
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19
Blood and lymphatic system disorders Periorbital Edema	5.3% 1/19 • Number of events 2
Cardiac disorders Myocardial infarction	5.3% 1/19 • Number of events 1

Other adverse events

Measure	Everolimus and Imatinib Mesylate n=19 participants at risk Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Blood and lymphatic system disorders Decreased Hematrocrit	5.3% 1/19
Blood and lymphatic system disorders Decreased Hemoglobin	31.6% 6/19 • Number of events 6
Blood and lymphatic system disorders Decreased Lymphocytes	5.3% 1/19
Blood and lymphatic system disorders Decreased Platelet Count	10.5% 2/19 • Number of events 2
Blood and lymphatic system disorders Increased Bun	5.3% 1/19 • Number of events 1
Blood and lymphatic system disorders Low Hemoglobin	5.3% 1/19 • Number of events 1
Blood and lymphatic system disorders Low Platelet Count	15.8% 3/19 • Number of events 3
Blood and lymphatic system disorders Low White Blood Cell Count	10.5% 2/19 • Number of events 2
Blood and lymphatic system disorders Lymphomenia	5.3% 1/19 • Number of events 1
Blood and lymphatic system disorders Lymphopemia	5.3% 1/19 • Number of events 1
Blood and lymphatic system disorders Lymphopenia	10.5% 2/19 • Number of events 2
Blood and lymphatic system disorders Neutropenia	15.8% 3/19 • Number of events 3
Cardiac disorders Bradycardia	5.3% 1/19 • Number of events 1
Cardiac disorders Hypertension	10.5% 2/19 • Number of events 2
Cardiac disorders Mild congestive heart failure	5.3% 1/19 • Number of events 1
Cardiac disorders Pericardial effusion	5.3% 1/19 • Number of events 1
Cardiac disorders Unstable angina	5.3% 1/19 • Number of events 1
General disorders Chills/Rigors	5.3% 1/19 • Number of events 1
General disorders Dizziness	5.3% 1/19 • Number of events 1
General disorders Fever	21.1% 4/19 • Number of events 4
General disorders Insomnia	5.3% 1/19 • Number of events 1
General disorders Weight Loss	15.8% 3/19 • Number of events 3
Skin and subcutaneous tissue disorders Abrasions: face, chest, arm	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders Allergic reaction: hives	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders Bruising on Abdomen	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders Diabetic ulcer: toe	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders Ecchymosis	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders FACIAL FLUSHING	10.5% 2/19 • Number of events 2
Metabolism and nutrition disorders ANOREXIA	68.4% 13/19 • Number of events 13
Gastrointestinal disorders Dehydration	21.1% 4/19
Gastrointestinal disorders Dysgeusia	10.5% 2/19
Gastrointestinal disorders Dysguesia	10.5% 2/19
Gastrointestinal disorders Dyspepsia	21.1% 4/19
Gastrointestinal disorders NAUSEA	78.9% 15/19
Blood and lymphatic system disorders Hematuria	15.8% 3/19
Musculoskeletal and connective tissue disorders Muscles weakness	5.3% 1/19
Psychiatric disorders Depression	5.3% 1/19
General disorders Abdominal Pain	15.8% 3/19

Additional Information

Christopher W. Ryan

Oregon Health and Science University

Phone: 503-494-1951

Email: ryanc@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place