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

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ClinicalTrials.gov Identifier: NCT00331409
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : October 5, 2011
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christopher Ryan, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Interventions Drug: Everolimus
Drug: imatinib mesylate
Enrollment 23
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Everolimus and Imatinib Mesylate
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Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Period Title: Overall Study
Started 19 [1]
Completed 15 [2]
Not Completed 4
Reason Not Completed
Lack of Efficacy             4
[1]
19 patients were enrolled in the first stage due to 4 patients who withdrew early.
[2]
15 patients accrued to the first stage;if>9 were progression-free at 3 months,enrollment continued.
Arm/Group Title Everolimus and Imatinib Mesylate
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Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Overall Number of Baseline Participants 19
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  47.4%
>=65 years
10
  52.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
65  (7.7459)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
3
  15.8%
Male
16
  84.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Progression-free Survival at 3 Months
Hide Description [Not Specified]
Time Frame 3 months post 1st dose
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[Not Specified]
Arm/Group Title Everolimus and Imatinib Mesylate
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Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
2.9
(1.9 to 6.2)
2.Primary Outcome
Title Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months
Hide Description [Not Specified]
Time Frame Up to 4 years
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[Not Specified]
Arm/Group Title Everolimus and Imatinib Mesylate
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Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
18
3.Secondary Outcome
Title Median Time to Progression
Hide Description [Not Specified]
Time Frame Time to progression
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[Not Specified]
Arm/Group Title Everolimus and Imatinib Mesylate
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Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
2.9
(1.9 to 6.2)
4.Secondary Outcome
Title Number of Subjects That Demonstrated a Reduction in Tumor Measurements.
Hide Description 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.
Time Frame Up to 4 years
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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.
Arm/Group Title Everolimus and Imatinib Mesylate
Hide Arm/Group Description:

Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
5
  29.4%
5.Secondary Outcome
Title Number of Participants With Adverse Events
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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.

Time Frame Duration of study, Up to 4 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Everolimus and Imatinib Mesylate
Hide Arm/Group Description:

Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Everolimus and Imatinib Mesylate
Hide Arm/Group Description

Everolimus: 2.5 mg daily by mouth

Imatinib Mesylate: 600 mg daily by mouth

All-Cause Mortality
Everolimus and Imatinib Mesylate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus and Imatinib Mesylate
Affected / at Risk (%) # Events
Total   10/19 (52.63%)    
Blood and lymphatic system disorders   
Anemia  4/19 (21.05%)  4
Angioedema Tongue  1/19 (5.26%) 
Periorbital Edema  1/19 (5.26%)  2
Cardiac disorders   
Hypotension  1/19 (5.26%) 
Myocardial infarction  1/19 (5.26%)  1
Gastrointestinal disorders   
Diarrhea  1/19 (5.26%) 
General disorders   
Fatigue  2/19 (10.53%) 
Infections and infestations   
Pneumonitis  1/19 (5.26%) 
Urinary Tract Infrection  1/19 (5.26%) 
Renal and urinary disorders   
Renal Failure  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusions  3/19 (15.79%) 
Hypoxia  1/19 (5.26%) 
Dyspnea  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Rash  1/19 (5.26%) 
Vascular disorders   
Syncope  1/19 (5.26%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus and Imatinib Mesylate
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Decreased Hematrocrit  1/19 (5.26%) 
Decreased Hemoglobin  6/19 (31.58%)  6
Decreased Lymphocytes  1/19 (5.26%) 
Decreased Platelet Count  2/19 (10.53%)  2
Increased Bun  1/19 (5.26%)  1
Low Hemoglobin  1/19 (5.26%)  1
Low Platelet Count  3/19 (15.79%)  3
Low White Blood Cell Count  2/19 (10.53%)  2
Lymphomenia  1/19 (5.26%)  1
Lymphopemia  1/19 (5.26%)  1
Lymphopenia  2/19 (10.53%)  2
Neutropenia  3/19 (15.79%)  3
Hematuria  3/19 (15.79%) 
Cardiac disorders   
Bradycardia  1/19 (5.26%)  1
Hypertension  2/19 (10.53%)  2
Mild congestive heart failure  1/19 (5.26%)  1
Pericardial effusion  1/19 (5.26%)  1
Unstable angina  1/19 (5.26%)  1
Gastrointestinal disorders   
Dehydration  4/19 (21.05%) 
Dysgeusia  2/19 (10.53%) 
Dysguesia  2/19 (10.53%) 
Dyspepsia  4/19 (21.05%) 
NAUSEA  15/19 (78.95%) 
General disorders   
Chills/Rigors  1/19 (5.26%)  1
Dizziness  1/19 (5.26%)  1
Fever  4/19 (21.05%)  4
Insomnia  1/19 (5.26%)  1
Weight Loss  3/19 (15.79%)  3
Abdominal Pain  3/19 (15.79%) 
Metabolism and nutrition disorders   
ANOREXIA  13/19 (68.42%)  13
Musculoskeletal and connective tissue disorders   
Muscles weakness  1/19 (5.26%) 
Psychiatric disorders   
Depression  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Abrasions: face, chest, arm  1/19 (5.26%)  1
Allergic reaction: hives  1/19 (5.26%)  1
Bruising on Abdomen  1/19 (5.26%)  1
Diabetic ulcer: toe  1/19 (5.26%)  1
Ecchymosis  1/19 (5.26%)  1
FACIAL FLUSHING  2/19 (10.53%)  2
Our phase II study closed after the first stage of accrual due to an insufficient number of participants who remained progression-free at 3 months, per the study design.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher W. Ryan
Organization: Oregon Health and Science University
Phone: 503-494-1951
EMail: ryanc@ohsu.edu
Layout table for additonal information
Responsible Party: Christopher Ryan, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00331409     History of Changes
Other Study ID Numbers: IRB00001754
OHSU-SOL-05108-LM ( Other Identifier: OHSU Knight Cancer Institute )
FWA00000161 ( Other Identifier: OHSU IRB )
OHSU-1754 ( Other Identifier: OHSU IRB )
CDR0000479150 ( Other Identifier: NCI PDQ )
First Submitted: May 30, 2006
First Posted: May 31, 2006
Results First Submitted: June 13, 2011
Results First Posted: October 5, 2011
Last Update Posted: October 26, 2017