Kidney CancerPhase 2NCT00331409
Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase 2 study testing Everolimus and imatinib mesylate in people with Kidney Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Everolimus and imatinib mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria:
- Measurable metastatic disease
- Locally unresectable disease
- No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery
- Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 8 g/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 2.5 times ULN
- Creatinine < 1.5 times ULN
- No New York Heat Association grade III-IV cardiac disease
- No other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant or inactive disease
- No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
- No severe or uncontrolled medical disease
- No gastrointestinal disease or impairment that would hinder the absorption of everolimus
- No uncontrolled diabetes
- No chronic renal disease
- No active uncontrolled infection
- No congestive heart failure
- No myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior major surgery
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C)
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since other prior investigational agents
- No prior radiotherapy to > 25% of bone marrow
- No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor
- No concurrent therapeutic warfarin
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
About this study
Official title: A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response [CR], partial response [PR], or stable disease [SD]) at 3 months after treatment with everolimus and imatinib mesylate.
Secondary
- Estimate median time to progression in patients treated with this regimen.
- Determine the proportion of patients whose best overall response are CR, PR, SD, or progressive disease.
- Evaluate the mean and range of the maximum percent reduction in tumor size.
- Describe the toxicities of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- Everolimus, imatinib mesylate
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Afinitor, RAD001, Certican
2.5 mg by mouth daily
imatinib mesylateDrug
Also called Gleevec, STI-571
600 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Everolimus and Imatinib Mesylate | Experimental | Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth Receives: Drug: Everolimus; Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival at 3 Months
Measured: 3 months post 1st dose
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months
Measured: Up to 4 years
Secondary outcomes (3)
Median Time to Progression
Measured: Time to progression
Number of Subjects That Demonstrated a Reduction in Tumor Measurements.
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.
Measured: Up to 4 years
Number of Participants With Adverse Events
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.
Measured: Duration of study, Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christopher Ryan, OHSU Knight Cancer Institute
- Investigators
- Christopher W. Ryan, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331409
- Sponsor's protocol ID
- IRB00001754
- Other IDs
- OHSU-SOL-05108-LM, FWA00000161, OHSU-1754, CDR0000479150
- Status last verified
- Sep 2017
- First submitted
- 30 May 2006
- Last updated
- 26 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
- ClinicalTrials.gov ID
- NCT00331409
- Acronym / sponsor ID
- IRB00001754
- Conditions
- Kidney Cancer
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 May 2006 (estimated)
- Results
- Posted 5 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response [CR], partial response [PR], or stable disease [SD]) at 3 months after treatment with everolimus and imatinib mesylate.
Secondary
- Estimate median time to progression in patients treated with this regimen.
- Determine the proportion of patients whose best overall response are CR, PR, SD, or progressive disease.
- Evaluate the mean and range of the maximum percent reduction in tumor size.
- Describe the toxicities of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus and Imatinib Mesylate | Experimental | Drug: Everolimus, Drug: imatinib mesylateEverolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusAlso: Afinitor, RAD001, Certican2.5 mg by mouth daily | Drug | Everolimus and Imatinib Mesylate |
| imatinib mesylateAlso: Gleevec, STI-571600 mg by mouth daily | Drug | Everolimus and Imatinib Mesylate |
Primary outcome
Progression-free Survival at 3 Months
Time frame: 3 months post 1st dose
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months
Time frame: Up to 4 years
3 secondary outcomes
Median Time to Progression
Time frame: Time to progression
Number of Subjects That Demonstrated a Reduction in Tumor Measurements.
Time frame: Up to 4 years
Number of Participants With Adverse Events
Time frame: Duration of study, Up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Kidney Cancer
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher W. Ryan, MD study chair
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus and imatinib mesylate in people with Kidney Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival at 3 Months (time frame: 3 months post 1st dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.