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A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798446
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : December 8, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Se-Hoon Lee, Seoul National University Hospital

Brief Summary:
  • 1. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC).
  • 2. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF treatment.
  • 3. There is no trial of axitinib for non-clear cell RCC.
  • 4. Axitinib is expected to show more potent efficacy over sorafenib or sunitinib in renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Nonclear Cell Temsirolimus Resistance Drug: Axitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Axitinib
This is a single arm study. Axitinib arm is the only arm who receive axitinib.
Drug: Axitinib
Axitinib 5mg twice will be orally administered daily with one cycle of 4 weeks. The package of axitinib must be opened right before the administration due to its photosensitivity.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Followed up during study drug administration till disease progression, unacceptable toxicitiy, or 1 year ]
    PFS is a time from study enrollment to documented disease progression or death from any cause


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: Every 8 weeks till disease progression, unacceptable toxicity or 1 year ]
    Tumor response according to Response Evaluation Criteria for Solid Tumor (RECIST) criteria version 1.1

  2. Disease control rate (DCR) [ Time Frame: Every 8 weeks till disease progression, unacceptable toxicity or 1 year ]
    Disease control (complete remission + partial remission + stable disease) rate according to RECIST criteria version 1.1

  3. Overall survival [ Time Frame: Every 8 weeks till disease progression, unacceptable toxicity or 1 year ]
    Duration from study enrollment to death from any cause

  4. Number of patients who experience adverse events related to drug and serious adverse events [ Time Frame: Every 4 weeks till disease progression, unacceptable toxicity or 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmation of RCC without a clear cell histologic component, e.g., papillary type, chromophobe type, medullary type or unclassified)
  • Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Previous treatment with temsirolimus
  • Measurable disease according to RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Age 18 years or older
  • Adequate cardiac function
  • Adequate bone marrow, hepatic, and renal function
  • Hematology:

Neutrophil same or more than 1.5 x 10^9/L Platelet same or more than 75 x 10^9/L Hemoglobin same or more than 9 g/dL -Liver function tests: Total bilirubin same or less than 1.5 x upper limit normal (xULN) aspartate aminotransferase(AST), alanine aminotransferase (ALT) same or less than 2.5 xULN Alkaline phosphatase same or less than 2.5 xULN

-Renal function tests: Creatinine clearance same or more than 30 mL/min

  • Life expectancy more than 3 months
  • Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  • Clear cell type RCC
  • Composed of mostly sarcomatoid carcinoma
  • Collecting duct type RCC
  • Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
  • Hypertension that cannot be controlled by medications (blood pressure 150/90 mmHg despite optimal medical therapy)
  • Pregnancy or breast feeding
  • Other severe acute or chronic medical or psychiatric condition
  • Prior treatment on sunitinib, sorafenib, pazopanib or bevacizumab
  • Uncontrolled central nerve system (CNS) metastasis (brain and/or leptomeningeal metastasis)
  • Patients who require concomitant treatment with potent cytochrome P 3A4 ( CYP3A4) inducers and inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798446


Locations
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Korea, Republic of
Seou National University Hospital
Seoul, Korea, Republic of, 110744
Sponsors and Collaborators
Seoul National University Hospital
Pfizer
Investigators
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Principal Investigator: Se-Hoon Lee, MD, PhD Seoul National University Hospital
Additional Information:
Publications:
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Responsible Party: Se-Hoon Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01798446    
Other Study ID Numbers: H-1301-124-461
SNUH_Axitinib_NCCRCC ( Other Identifier: SNUH )
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Keywords provided by Se-Hoon Lee, Seoul National University Hospital:
Renal cell carcinoma
Nonclear cell
Temsirolimus resistance
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action