Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Hormones

Docetaxel

Prednisone

Sunitinib

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

SU011248 in combination with docetaxel and prednisone

Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks).

Prednisone Phase1/2 - 5 mg twice a day (BID), oral.

SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1).

SU011248

Pfizer CT.gov Call Center

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).

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

A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)

PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.

Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date - first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) \[or back to baseline\] and for patients without a PSA response as a 25% increase over baseline \[or nadir (lowest)\] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value.

Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir \[lowest\] and increase in absolute-value PSA level by at least 5 ng/mL \[or back to baseline\] and for patients without a PSA response as a 25% increase over baseline \[or nadir / lowest\] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR - first PSA response + 1)/7.

Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (\>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).

Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (\>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).

Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (\>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).

Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions \[LD\] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD \<3 months.

Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions \[LD\] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD \<3 months.

Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions \[LD\] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD \<3 months.

The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status.

The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference.

Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status.

PSA modulation analyzed by the mean change in PSA response measured as ng/mL.

Pfizer

SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily

SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg

Age, Categorical

Age Continuous

Sex: Female, Male

Per FDAAA, only the Phase 2 study results are posted.

Pfizer Clinical Trials.gov Call Center

The intent-to-treat (ITT) population was defined as all patients enrolled in the study that receive at least 1 dose of study medication (SU011248 or docetaxel)

Percentage of Participants With Prostate Specific Antigen (PSA) Response

Time to PSA Progression

ITT; DPR only calculated for the subgroup of patients with PSA response rate.

Duration of PSA Response (DPR)

ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type.

Percentage of Participants With Objective Response Rate (ORR)

Bsl median - PSA responder

Bsl median - PSA non-responder

C1D14 : C1D1 - PSA responder

C1D14 : C1D1 - PSA non-responder

C2.D1 : C1D1 - PSA responder

C2.D1 : C1D1 - PSA non-responder

C2.D14 : C1D1 - PSA responder

C2.D14 : C1D1 - PSA non-responder

C3.D1 : C1D1 - PSA responder

C3.D14 : C1D1 - PSA responder

C3.D14 : C1D1 - PSA non-responder

Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3

Bsl median - CR or PR

Bsl median - SD or PD

C1D14 : C1D1 - CR or PR

C1D14 : C1D1 - SD or PD

C2.D1 : C1D1 - CR or PR

C2.D1 : C1D1 - SD or PD

C2.D14 : C1D1 - CR or PR

C2.D14 : C1D1 - SD or PD

C3.D14 : C1D1 - CR or PR

C3.D14 : C1D1 - SD or PD

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3

Bsl mean C1.D1 (n=48)

Change from Bsl - C2.D1 (n=42)

Change from Bsl - C3.D1 (n=35)

Change from Bsl - C4.D1 (n=30)

Change from Bsl - C5.D1 (n=32)

Change from Bsl - C6.D1 (n=32)

Change from Bsl - C7.D1 (n=29)

Change from Bsl - C8.D1 (n=26)

Change from Bsl - C9.D1 (n=25)

Change from Bsl - C10.D1 (n=22)

Change from Bsl - C11.D1 (n=21)

Change from Bsl - C12.D1 (n=18)

Change from Bsl - C13.D1 (n=17)

Change from Bsl - C14.D1 (n=17)

Change from Bsl - C15.D1 (n=12)

Change from Bsl - C16.D1 (n=12)

Change from Bsl - EOT (n=37)

Patient reported outcomes (PRO) evaluable population defined as participants in the ITT population who received at least 1 dose of study medication (sunitinib or docetaxel) and had baseline data; (n)=number of participants with evaluable data at observation.

Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)

Change from Bsl - C2.D1 (n=41)

Change from Bsl - C3.D1 (n=34)

Change from Bsl - C5.D1 (n=31)

Change from Bsl - C9.D1 (n=24)

Change from Bsl - C10.D1 (n=21)

Change from Bsl - EOT (n=36)

PRO evaluable population; (n)=number of participants with evaluable data at observation.

Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)

Bsl mean C1.D1 (n=47)

Change from Bsl - C3.D1 (n=31)

Change from Bsl - C5.D1 (n=33)

Change from Bsl - C6.D1 (n=31)

Change from Bsl - C8.D1 (n=25)

Change from Bsl - C13.D1 (n=16)

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)

ITT population; PSA modulation was listed as a secondary endpoint for Phase 2, however, modulation was planned for analysis only for Phase 1 portion of the study. No formal analysis was completed to determine modulation.

Preliminary Assessment of PSA Modulation by SU011248

Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m\^2) + Prednisone 5 mg given twice daily

Spots Global Cancer Trial Database for Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

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