Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

NCT00854620 | Completed Phase 2 Results DMC

• 4 other identifiers: IRB-0498896919SU-02272009-1898RENAL0009
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Renal Cell; Kidney Disease; Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Time-to-progression (TTP)

  12 months

Study Arms (1)

Sorafenib

EXPERIMENTAL

* Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib

Drug: Sorafenib

Interventions

Sorafenib DRUG

Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)

Also known as: Nexavar, Sorafenib tosylate

Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
• must have a component of conventional clear cell renal carcinoma.
• No more than one prior systemic therapy.
• No prior vascular endothelial growth factor receptor agents.
• 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.
• 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.
• Measureable disease by RECIST criteria
• Karnofsky performance status at least 70% or ECOG not more than 2
• Ability to give written informed consent
• At least 18 years old
• Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
• Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
• ANC at least 1,500/uL
• Platelet count at least 100,000/uL
• AST/ALT not more than 2.5 times the upper limit of normal (ULN)

You may not qualify if:

• Ongoing hemoptysis
• Cerebrovascular accident within 12 months
• Peripheral vascular disease with claudication on less than 1 block
• History of clinically significant bleeding
• Malignancy with true papillary/sarcomatoid features without any clear cell component
• Chromophobe
• Oncocytoma
• Collecting duct tumors
• Transitional cell carcinoma
• Deep venous thrombosis or pulmonary embolus within one year of consent
• 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
• Subjects with evidence of current central nervous system (CNS) metastases
• MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
• Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
• Angina pectoris requiring nitrate therapy

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Diseases; Kidney Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Sandy Srinivas, MD
• Organization: Stanford University, Stanford Cancer Center

sandysri@stanford.edu

650-725-2078

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 3, 2009
• Study Start: December 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2011
• Last Updated: June 19, 2015
• Results First Posted: January 14, 2015

Record last verified: 2015-05

Locations

US (1)