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Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Phase 1
18 Years
75 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate glad.

- Informed of, willing, and able to comply with, the requirements of the
investigational study and have signed a written informed consent in accordance with
institutional regulatory guidelines.

- Subjects defined as being at high risk for disease relapse based on the following
criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.

- Patients must have elected to and are a candidate to undergo a radical prostatectomy.

- Males greater than 18 years of age and less than or equal to 75 years of age
(physiologic) any racial/ethnic group.

- Free of significant abnormal findings as determined by screening history, physical
exam, vital signs (blood pressure, heart rate, respiration rate, and temperature),
and urinalysis.

- Performance status: ECOG < 2.

- Life expectancy of at least 5 years.

- Absolute granulocyte count > 1,500/mm3.

- Platelet count > 100,000.

- Hemoglobin > 9.0 g/dL.

- Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST
values within normal range. Adequate organ function as defined by the following
criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase
[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase
[SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x
ULN if liver function abnormalities are due to underlying malignancy.

- Creatinine < 1.5 ULN.

Exclusion Criteria:

- Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.

- Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy,
biological response modifiers, or systematic chemotherapy to treat prostatic

- Surgery within four weeks of study entry.

- Evidence of regional and/or distant metastases.

- Use of an investigational drug within 30 days prior to study entry.

- NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study

- Any of the following thing the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.

- Prolonged QTc interval on baseline EKG.

- Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).

- Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit
juice or St. John's Wort while on the study

- Known active infection.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Arie Belldegrun, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatectomy
  • Prostatic Neoplasms



University of California, Los Angeles, Jonsson Comprehensive Cancer Center Los Angeles, California  90095