Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma

NCT01108445

Last updated date
Study Location
University of Chicago
Chicago, Illinois, 60637, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Non-clear Cell Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Histologically confirmed advanced Renal Cell Carcinoma (RCC), with non-clear cell pathology.

2. RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both.

3. At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.0) Grade 1.

4. Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria (Attachment 1)].

5. Age > 18 years.

6. Adequate laboratory values

7. Karnofsky Performance Status ≥ 60 (Attachment 2).

8. Life expectancy of at least 3 months.

9. Written, signed, dated, and witnessed Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approved informed consent form (ICF) before any screening procedures are performed.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Subjects with a history of or active central nervous system (CNS) metastases.


2. Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy,
chemotherapy, biologic or experimental therapy.


3. Subjects with collecting duct, medullary, small cell, oncocytoma, or lymphoma-type
pathology.


4. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.


5. Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the
screening visit.


6. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or
radiation therapy.


7. Presence of a non-healing wound or ulcer.


8. Grade 3 hemorrhage within the past month.


9. Hypertension with systolic blood pressure of >180 mm Hg and/or diastolic pressure >100
mm Hg.


10. Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history
of congestive heart failure with an ejection fraction <50%, or history of unstable
angina, myocardial infarction, coronary artery bypass graft, cerebrovascular accident,
transient ischemic attack, or pulmonary embolism within 6 months of entry.


11. Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 10% despite therapy.


12. A history of interstitial pneumonitis.


13. Subjects with active autoimmune disorder(s) being treated with immunosuppressive
agents within 4 weeks prior to the screening visit.


14. Subjects receiving immunosuppressive agents and those with chronic
viral/bacterial/fungal illnesses such as human immunodeficiency virus (HIV).


15. Patients who have receive immunization with attenuated live vaccines within one week
of study entry or during study period.


16. Patients with active infection(s), active antimicrobial therapy or serious
intercurrent illness.


17. History of other prior malignancy in past 5 years.


18. Pregnant or nursing women.


19. Major medical/psychiatric illness that, in the investigator's judgment, will
substantially increase the risk associated with the subject's participation in this
study, including inability to absorb oral medications and history of noncompliance to
medical regimens.


20. Known hypersensitivity to any of the components in everolimus or sunitinib product


21. Subjects taking agents that significantly prolong the QTc interval are not eligible.


22. Proteinuria with a spot urine protein/creatinine ratio >2 or 24 hour urine protein >2
grams per 24 hours.


23. Severely impaired lung function as defined as spirometry and Carbon Monoxide Diffusing
Capacity (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is
88% or less at rest on room air.


24. Advanced liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh
class C).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Advanced Non-clear Cell Renal Cell CarcinomaPhase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma
NCT01108445
  1. Chicago, Illinois
  2. Indianapolis, Indiana
  3. Detroit, Michigan
  4. Saint Louis, Missouri
  5. Durham, North Carolina
  6. Cleveland, Ohio
  7. Portland, Oregon
  8. Nashville, Tennessee
  9. Nashville, Tennessee
  10. Vancouver, British Columbia
  11. Winnipeg, Manitoba
  12. London, Ontario
  13. Cambridge, England
  14. London, England
  15. Manchester, England
  16. Sheffield, England
  17. Headington, Oxford
  18. Glasgow, Scottland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma
Official Title  ICMJE A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
Brief Summary To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.
Detailed Description This will be an international (USA, Canada, and UK) open-label, outpatient, multicenter, randomized study of treatment with RAD001 (everolimus (Afinitor®) or sunitinib (Sutent®) in subjects with mRCC and non-clear cell histology. Special emphasis is placed on papillary and chromophobe histologies while sarcomatoid clear cell variants, medullary, and collecting duct carcinomas will be excluded (see eligibility). Subjects may continue receiving study drugs until disease progression, unacceptable toxicities, or withdrawal of consent, for a maximum of 24 months. Continuation of study assigned treatment will be allowed beyond 24 months at the discretion of the sponsor. Stratification variables will include histology (papillary vs. chromophobe) and Motzer risk criteria (0, 1-2, and 3). Tumor progression will be assessed locally and by independent review, in strict accordance with Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria measured every 12 weeks. At the time of progression, subjects will be taken off study other than simple administrative mortality follow-up. Primary pathologic samples and plasma/urine angiokine levels at baseline and over time will be collected and stored centrally for biomarker analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non-clear Cell Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Everolimus
    Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
    Other Name: Afinitor, everolimus, RAD001
  • Drug: Sunitinib
    50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
    Other Name: Sutent
Study Arms  ICMJE
  • Active Comparator: RAD001
    Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
    Intervention: Drug: Everolimus
  • Active Comparator: Sunitinib
    Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
    Intervention: Drug: Sunitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
131
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
108
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed advanced Renal Cell Carcinoma (RCC), with non-clear cell pathology.
  2. RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both.
  3. At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.0) Grade 1.
  4. Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria (Attachment 1)].
  5. Age > 18 years.
  6. Adequate laboratory values
  7. Karnofsky Performance Status ? 60 (Attachment 2).
  8. Life expectancy of at least 3 months.
  9. Written, signed, dated, and witnessed Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approved informed consent form (ICF) before any screening procedures are performed.

Exclusion Criteria:

  1. Subjects with a history of or active central nervous system (CNS) metastases.
  2. Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy, chemotherapy, biologic or experimental therapy.
  3. Subjects with collecting duct, medullary, small cell, oncocytoma, or lymphoma-type pathology.
  4. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
  5. Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit.
  6. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
  7. Presence of a non-healing wound or ulcer.
  8. Grade 3 hemorrhage within the past month.
  9. Hypertension with systolic blood pressure of >180 mm Hg and/or diastolic pressure >100 mm Hg.
  10. Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <50%, or history of unstable angina, myocardial infarction, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of entry.
  11. Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 10% despite therapy.
  12. A history of interstitial pneumonitis.
  13. Subjects with active autoimmune disorder(s) being treated with immunosuppressive agents within 4 weeks prior to the screening visit.
  14. Subjects receiving immunosuppressive agents and those with chronic viral/bacterial/fungal illnesses such as human immunodeficiency virus (HIV).
  15. Patients who have receive immunization with attenuated live vaccines within one week of study entry or during study period.
  16. Patients with active infection(s), active antimicrobial therapy or serious intercurrent illness.
  17. History of other prior malignancy in past 5 years.
  18. Pregnant or nursing women.
  19. Major medical/psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications and history of noncompliance to medical regimens.
  20. Known hypersensitivity to any of the components in everolimus or sunitinib product
  21. Subjects taking agents that significantly prolong the QTc interval are not eligible.
  22. Proteinuria with a spot urine protein/creatinine ratio >2 or 24 hour urine protein >2 grams per 24 hours.
  23. Severely impaired lung function as defined as spirometry and Carbon Monoxide Diffusing Capacity (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air.
  24. Advanced liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01108445
Other Study ID Numbers  ICMJE Pro00020714
CRAD001L2402T ( Other Identifier: Novartis )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Novartis
  • Pfizer
Investigators  ICMJE
Principal Investigator:Andrew Armstrong, MD, ScMDuke University
PRS Account Duke University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP