Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT00854620
First received: February 27, 2009
Last updated: May 20, 2015
Last verified: May 2015
  Purpose

Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib


Condition Intervention Phase
Carcinoma, Renal Cell
Kidney Disease
Kidney Cancer
Drug: Sorafenib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time-to-progression (TTP) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: December 2007
Study Completion Date: January 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib
  • Cycle 1: 400 mg BID sorafenib
  • Cycle 2: 600 mg BID sorafenib
  • Cycle 3+: 800 mg BID sorafenib
Drug: Sorafenib
Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
Other Names:
  • Nexavar
  • Sorafenib tosylate

Detailed Description:

Sorafenib to be administered as 28-day cycles.

Sorafenib dose escalation by cycle is:

  • Cycle 1: 400 mg BID
  • Cycle 2: 600 mg BID
  • Cycle 3+: 800 mg BID

Within subject dose escalation and maximum dose is dependent on observed tolerability.

Dose escalation only occurs after acceptable tolerability is demonstrated by subject.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
  2. must have a component of conventional clear cell renal carcinoma.
  3. No more than one prior systemic therapy.
  4. No prior vascular endothelial growth factor receptor agents.
  5. Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.
  6. All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.
  7. Measureable disease by RECIST criteria
  8. Karnofsky performance status at least 70% or ECOG not more than 2
  9. Ability to give written informed consent
  10. At least 18 years old
  11. Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
  12. Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
  13. ANC at least 1,500/uL
  14. Platelet count at least 100,000/uL
  15. AST/ALT not more than 2.5 times the upper limit of normal (ULN)
  16. Alkaline phosphatase not more than 2.5 x ULN
  17. Serum bilirubin not more than 1.5 x ULN
  18. Amylase/Lipase within normal range
  19. Urinalysis not more than 1+ protein
  20. Serum creatinine not more than 1.5 x ULN
  21. No active ischemia by ECG
  22. Echocardiogram or MUGA ejection fraction at least 40%

Exclusion Criteria:

  1. Ongoing hemoptysis
  2. Cerebrovascular accident within 12 months
  3. Peripheral vascular disease with claudication on less than 1 block
  4. History of clinically significant bleeding
  5. Malignancy with true papillary/sarcomatoid features without any clear cell component
  6. Chromophobe
  7. Oncocytoma
  8. Collecting duct tumors
  9. Transitional cell carcinoma
  10. Deep venous thrombosis or pulmonary embolus within one year of consent
  11. Ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed
  12. Subjects with evidence of current central nervous system (CNS) metastases
  13. MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
  14. Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
  15. Angina pectoris requiring nitrate therapy
  16. Myocardial infarction within the last 6 months
  17. Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)
  18. Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
  19. Uncontrolled psychiatric disorder
  20. Delayed healing of wounds, ulcers, and/or bone fractures
  21. Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed > 5 years ago and from which the patient has been disease-free for > 5 years)
  22. Pregnant
  23. Currently lactating
  24. Currently using St John's Wort (an herb)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854620

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00854620     History of Changes
Other Study ID Numbers: IRB-04988, 96919, SU-02272009-1898, RENAL0009
Study First Received: February 27, 2009
Results First Received: January 6, 2015
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015