Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854620
• Other study ID #: IRB-04988
• Secondary ID: 96919SU-02272009
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2009
• Last updated: May 20, 2015
• Start date: December 2007
• Est. completion date: January 2011

Study information

• Verified date: May 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Disease
• Kidney Diseases
• Kidney Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-progression (TTP)		12 months	No