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Carfilzomib in Refractory Renal Cell Carcinoma (RCC)

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: NCT01775930
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is learn if carfilzomib can help control kidney cancer. The safety of this drug will also be studied.

Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.


Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: Carfilzomib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma
Actual Study Start Date : October 2013
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019


Arm Intervention/treatment
Experimental: Carfilzomib
Patients receive Carfilzomib at dose of 20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
Drug: Carfilzomib
20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy [ Time Frame: The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months ]
    Progression free survival defined as time from enrollment to progression or death, whichever comes first. Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months ]
    The number of participants had a complete response (CR, complete reduction in tumor burden) or partial response (PR, a reduction in tumor burden of at least 30%) as determined for radiographic imaging such as a CT scan. Participants who do not have a reduction in tumor burden will either have stable disease (SD) or progressive disease (PD, which is an increase in tumor burden of at least 20%). The results are based on the best response that each participant achieved while on treatment.

  2. Overall Survival (OS) [ Time Frame: 15 months ]
    The number of months from the time of enrollment until death per participant

  3. Safety of Carfilzomib [ Time Frame: 4 months ]
    Reason for stopping therapy

  4. PFS and ORR as a Function of VHL Mutation Subtype [ Time Frame: No data collected ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Biopsy proven clear cell kidney cancer with metastatic disease. Progressive disease or intolerance to at least one but not more than three (3) prior systemic therapy(ies)
  2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
  3. Age >/= 18 years
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  5. Adequate hepatic function with serum ALT and AST </= 3.0 times the upper limit of normal and serum direct and total bilirubin </= 1.5 times the upper limit of normal.
  6. Absolute neutrophil count (ANC) >/= 1.0 × 10^9/L; patients with an ECOG performance status of 2 at study entry must have an ANC >/= 1.5 x 10^9/L
  7. Hemoglobin >/= 8 g/dL (80 g/L) within 14 days prior to beginning study treatment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines); Patients with an ECOG performance status of 2 at study entry must have a hemoglobin >/= 9 g/dL (transfusion assistance acceptable)
  8. Platelet count >/= 50 × 10^9/L; Patients with an ECOG performance status of 2 at study entry must have a platelet count >/= 100 × 10^9/L
  9. Creatinine clearance (CrCl) >/= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
  10. Written informed consent in accordance with federal, local, and institutional guidelines.
  11. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
  12. Male subjects must agree to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug

Exclusion Criteria:

  1. Brain metastases not controlled with surgery, whole brain radiotherapy, or with stereotactic radiosurgery
  2. Systemic therapy within two weeks of treatment initiation
  3. Pregnant or lactating females
  4. Major surgery within 21 days prior to beginning study treatment
  5. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to beginning study treatment
  6. Known human immunodeficiency virus infection
  7. Active hepatitis B or C infection
  8. Unstable angina or myocardial infarction within 4 months prior to beginning study treatment, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
  9. Uncontrolled hypertension (defined by BP consistently > 150/100) or uncontrolled diabetes (defined by HbA1c > 8.5) within 14 days prior to beginning study treatment
  10. Nonhematologic malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
  11. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to beginning study treatment
  12. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
  13. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
  14. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to beginning study treatment
  15. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

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): NCT01775930


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Onyx Therapeutics, Inc.
Investigators
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Principal Investigator: Eric Jonasch, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01775930    
Other Study ID Numbers: 2012-0694
NCI-2013-02350 ( Registry Identifier: NCI CTRP )
First Posted: January 25, 2013    Key Record Dates
Results First Posted: March 4, 2020
Last Update Posted: March 4, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Kidney Cancer
Refractory Renal Cell Carcinoma
RCC
Clear cell kidney cancer with metastatic disease
Carfilzomib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases