Phase 2 Completed N=55 Treatment

Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

Source: ClinicalTrials.gov NCT00137436 ↗

Enrolled (actual)

Serious AEs

50.9%

Results posted

Feb 2010

Primary outcomePrimary: Percentage of Participants With Prostate Specific Antigen (PSA) Response — 56.4 percentage of participants

Summary

This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Prostate Specific Antigen (PSA) Response	56.4	—
SECONDARY Time to PSA Progression	42.1	—
SECONDARY Duration of PSA Response (DPR)	39.1	—
SECONDARY Percentage of Participants With Objective Response Rate (ORR)	42.4	—
SECONDARY Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC	622.70; 639.70; 1.06; 1.07; 0.88; 0.93	0.942
SECONDARY Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2	9889.00; 10324.00; 0.73; 0.68; 0.80; 0.79	0.736
SECONDARY Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3	22475.00; 22070.00; 0.69; 0.73; 0.75; 0.75	0.386
SECONDARY Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC	581.05; 586.85; 1.21; 1.19; 0.89; 1.15	0.839
SECONDARY Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2	9837.50; 9484.25; 0.73; 0.75; 0.83; 0.83	0.656
SECONDARY Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3	19975.00; 22495.00; 0.72; 0.68; 0.78; 0.83	0.903
SECONDARY Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)	1.9; -1.0; -1.1; -0.8; -0.8; -0.8	—
SECONDARY Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)	1.8; -0.7; -0.8; -0.5; -0.7; -0.6	—
SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)	112.0; 6.4; 7.2; 6.6; 4.9; 8.2	—
SECONDARY Preliminary Assessment of PSA Modulation by SU011248	—	—

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate
Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy
Prior chemotherapy
Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)
History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec
Central Nervous System (CNS) involvement

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00137436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.