Phase 2
Completed N=95
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
Source: ClinicalTrials.gov NCT00385580 ↗Enrolled (actual)
95
Serious AEs
22.1%
Results posted
Mar 2011
Primary outcomePrimary: Number of Participants With a Response — 12; 13 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Response |
12; 13 | — |
| PRIMARY Percentage of Participants With a Response |
25.00; 27.70 | — |
| SECONDARY Number of Participants With a Decrease in PSA by at Least 50% From Baseline |
1; 1 | — |
| SECONDARY Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline |
2.3; 2.3 | — |
| SECONDARY Number of Months of Decrease in PSA by at Least 50% From Baseline |
0.82; 11.17 | — |
| SECONDARY Number of Participants With Decrease in PSA Velocity |
25; 16 | — |
| SECONDARY Number of Participants With Decrease in PSA Log Slope |
38; 34 | — |
| SECONDARY Number of Participants With Increase in PSA Doubling Time |
34; 32 | — |
| SECONDARY Number of Participants With CR or PR |
1; 0 | — |
| SECONDARY Number of Participants With CR, PR or SD |
11; 12 | — |
| SECONDARY Number of Participants With a Confirmed Improved Bone Scan |
0; 1 | — |
| SECONDARY Percentage of Participants With Confirmed Improved Bone Scan |
0.0; 2.6 | — |
| SECONDARY Number of Participants With Disease Progression |
30; 34 | — |
| SECONDARY Median Number of Months to Disease Progression |
4.7; 2.8 | — |
| SECONDARY Median Change From Baseline in Individual FAPSI Scores at Week 12 |
0.00; -1.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 |
0.00; -2.00; -2.50; -2.00; NA; NA | — |
| SECONDARY Median Change From Baseline in Individual FAPSI Scores at Week 24 |
0.00; 0.00; -0.50; -0.50; -0.50; -0.50 | — |
| SECONDARY Median Change From Baseline in Individual FAPSI Scores at Week 36 |
— | — |
| SECONDARY Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs |
2; 2; 48; 47; 10; 11 | — |
| SECONDARY Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. |
1; 6; 43; 47; 7; 15 | — |
| SECONDARY Number of Participants With Grade 3-4 Hematology Abnormalities |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium |
0; 0; 0; 0; 6; 0 | — |
| SECONDARY Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous |
0; 0; 0; 0; 2; 1 | — |
| SECONDARY Number of Participants With Abnormal Lactate Dehydrogenase (LD) |
33; 41 | — |
| SECONDARY Number of Participants With Positive Urinalysis |
20; 21; 2; 1; 21; 26 | — |
| SECONDARY Number of Participants With QTc Prolongation |
3; 10 | — |
| SECONDARY Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx |
2; 6; 13; 12; 5; 1 | — |
| SECONDARY Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx |
6; 4; 3; 9; 4; 1 | — |
| SECONDARY Number of Participants With a uNTx Response |
10; 10 | — |
| SECONDARY Median Number of Months of uNTx Response |
NA; NA | — |
| SECONDARY Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP |
12; 14; 5; 2; 1; 0 | — |
| SECONDARY Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP |
6; 6; 1; 3; 1; 0 | — |
| SECONDARY Number of Participants With BAP Response |
4; 5 | — |
| SECONDARY Median Number of Months of BAP Response |
NA; NA | — |
| SECONDARY Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) |
3.17; 8.15; 5.46; 102.98; 73.05; 83.24 | — |
| SECONDARY Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) |
15.46; 10.61; 8.68; 89.55; 59.75; 78.78 | — |
| SECONDARY Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) |
2.16; 11.69; 7.08; 140.15; 10.37; 66.47 | — |
| SECONDARY Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) |
7.29; 6.05; 54.67; 77.83; 30.98; 24.17 | — |
| SECONDARY Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) |
2.28; 7.39; 14.21; 60.35; 42.15; 117.71 | — |
| SECONDARY Mean Plasma Concentration at Dose 50 mg (Week 6) |
3.54; 7.43; 3.68; 134.89; 62.62; 31.99 | — |
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
Data sourced from ClinicalTrials.gov (NCT00385580). 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.