Clinical trial NCT00385580: Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
Official title: Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-10-09
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* males, 18 or older
* proven advanced prostate cancer
* documented metastatic disease
* rising PSA levels
* castrate levels of testosterone

Exclusion Criteria:

* symptomatic CNS (brain or spinal cord) metastasis
* medical condition which may increase the risk of toxicity
* any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents
* unable to take oral medication

Primary outcomes:
measure: Number of Participants With a Response
timeFrame: Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.
measure: Percentage of Participants With a Response
timeFrame: Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.
Secondary outcomes:
measure: Number of Participants With a Decrease in PSA by at Least 50% From Baseline
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Months of Decrease in PSA by at Least 50% From Baseline
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With Decrease in PSA Velocity
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With Decrease in PSA Log Slope
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With Increase in PSA Doubling Time
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With CR or PR
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Number of Participants With CR, PR or SD
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Number of Participants With a Confirmed Improved Bone Scan
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Percentage of Participants With Confirmed Improved Bone Scan
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Number of Participants With Disease Progression
timeFrame: Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.
measure: Median Number of Months to Disease Progression
timeFrame: Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.
measure: Median Change From Baseline in Individual FAPSI Scores at Week 12
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Median Change From Baseline in Individual FAPSI Scores at Week 24
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Median Change From Baseline in Individual FAPSI Scores at Week 36
timeFrame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
measure: Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs
timeFrame: From start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.
timeFrame: From start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Grade 3-4 Hematology Abnormalities
timeFrame: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.
measure: Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium
timeFrame: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.
measure: Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous
timeFrame: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.
measure: Number of Participants With Abnormal Lactate Dehydrogenase (LD)
timeFrame: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.
measure: Number of Participants With Positive Urinalysis
timeFrame: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.
measure: Number of Participants With QTc Prolongation
timeFrame: From start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With a uNTx Response
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Median Number of Months of uNTx Response
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Number of Participants With BAP Response
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Median Number of Months of BAP Response
timeFrame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
measure: Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)
timeFrame: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.
measure: Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)
timeFrame: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.
measure: Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)
timeFrame: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.
measure: Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)
timeFrame: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.
measure: Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)
timeFrame: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.
measure: Mean Plasma Concentration at Dose 50 mg (Week 6)
timeFrame: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Baltimore
country: United States
facility: The Bunting Blaustein Cancer Research Building
state: Maryland
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Madison
country: United States
facility: University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr
state: Wisconsin
city: Montpellier
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabro F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.