NCT01775930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 4, 2020

Completed
Last Updated

March 4, 2020

Status Verified

February 1, 2020

Enrollment Period

5.3 years

First QC Date

January 23, 2013

Results QC Date

January 2, 2020

Last Update Submit

February 21, 2020

Conditions

Kidney Cancer

Keywords

Kidney CancerRefractory Renal Cell CarcinomaRCCClear cell kidney cancer with metastatic diseaseCarfilzomib

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy

    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.

    The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months

Secondary Outcomes (4)

  • Overall Response Rate (ORR)

    Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months

  • Overall Survival (OS)

    15 months

  • Safety of Carfilzomib

    4 months

  • PFS and ORR as a Function of VHL Mutation Subtype

    No data collected

Study Arms (1)

Carfilzomib

EXPERIMENTAL

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

Interventions

CarfilzomibDRUG

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.

Carfilzomib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.
  • Age \>/= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • 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.
  • 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
  • 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)
  • 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
  • Creatinine clearance (CrCl) \>/= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
  • Written informed consent in accordance with federal, local, and institutional guidelines.
  • 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
  • Male subjects must agree to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug

You may not qualify if:

  • Brain metastases not controlled with surgery, whole brain radiotherapy, or with stereotactic radiosurgery
  • Systemic therapy within two weeks of treatment initiation
  • Pregnant or lactating females
  • Major surgery within 21 days prior to beginning study treatment
  • Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to beginning study treatment
  • Known human immunodeficiency virus infection
  • Active hepatitis B or C infection
  • 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
  • Uncontrolled hypertension (defined by BP consistently \> 150/100) or uncontrolled diabetes (defined by HbA1c \> 8.5) within 14 days prior to beginning study treatment
  • 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
  • Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to beginning study treatment
  • Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
  • 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
  • Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to beginning study treatment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Hasanov E, Tidwell RSS, Fernandez P, Park L, McMichael C, Tannir NM, Jonasch E. Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma. Clin Genitourin Cancer. 2019 Dec;17(6):451-456. doi: 10.1016/j.clgc.2019.07.003. Epub 2019 Jul 23.

    PMID: 31439537DERIVED

Related Links

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

carfilzomib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Dr. Eric Jonasch, MD / Professor, Genitourinary Medical Oncology
Organization
UT MD Anderson Cancer Center
ejonasch@mdanderson.org
713- 563-7232

Study Officials

  • Eric Jonasch, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 25, 2013

Study Start

October 1, 2013

Primary Completion

January 18, 2019

Study Completion

January 18, 2019

Last Updated

March 4, 2020

Results First Posted

March 4, 2020

Record last verified: 2020-02

Locations

US(1)