Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer
- Conditions
- castration-resistant metastatic prostate cancerMedDRA version: 18.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-000701-11-FI
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1875
1) Signed Written Informed Consent
a) Subjects must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
2) Target Population
a) History of histologically diagnosed prostate cancer.
b) Evidence of metastatic disease by any 1 of the following modalities: CT scan,MRI, bone scan, or skeletal survey.
c) Evidence of progression, as defined by 1 of the following (Protocol Appendix 2):
i) Rising PSA values at least 1 week apart with the final value being = 2 ng/mL, or
ii) Progression of measurable nodal or visceral disease:
(1) Nodal lesions must be = 20 mm
(2) Visceral lesions must be measurable per RECIST criteria, or
iii) Two (2) or more new lesions appearing on a bone scan compared with a prior scan, or
iv) Local recurrence in the prostate or prostate bed.
d) Maintaining castrate status: Subjects who have not undergone surgical orchiectomy should have received and continue on medical therapies [eg, gonadotropin releasing hormone analogs (GnRH/LHRH analogs)] to maintain castrate levels of serum testosterone = 50 ng/dL (1.7 nmol/L).
e) ECOG Performance Status 0 - 2 (Appendix 3).
f) At least 4 weeks since major surgery, radiotherapy, and an investigational agent.
g) At least 8 weeks since radioisotope therapy (eg, Strontium-89, Samarium-153 or similar agents).
h) Recovery from local primary therapy of surgery or radiation.
i) Required initial laboratory values:
i) WBC = 3,000/mm³.
ii) ANC = 1,500/mm3.
iii) Platelet count = 100,000/mm³.
iv) Creatinine = 1.5 x upper limits of normal.
v) Bilirubin = upper limit of normal (does not apply for subjects with Gilbert’s Disease).
vi) SGOT (AST) = 2.5 x upper limits of normal.
vii) SGPT (ALT) = 2.5 x upper limits of normal.
3) Age and Sex
a) Men only, at least 18 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 655
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1220
1) Sex and Reproductive Status
a) Women.
b) Sexually active fertile men not using effective birth control if their partners are WOCBP.
2) Target Disease Exceptions
a) Subjects with symptomatic brain metastases or leptomeningeal metastases are excluded from this clinical trial.
3) Medical History and Concurrent Diseases
a) Clinically significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc > 450 msec, ejection fraction (EF) < 40% or major conduction abnormality, unless a cardiac pacemaker is present.
b) Pleural or pericardial effusion of any CTC grade.
c) Peripheral neuropathy CTC Grade = 2.
d) Subjects with a currently active” second malignancy other than non-melanoma skin cancers are not to be enrolled into the study. Subjects are not considered to have a currently active” malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse.
e) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
f) HIV-positive subjects receiving combination anti-retroviral therapy.
4) Allergies and Adverse Drug Reactions
a) History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents.
5) Prohibited Treatments and/or Therapies (Protocol Section 5.5, Concomitant Therapies)
a) Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
b) No prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine.
c) Subjects may continue on a daily multi-vitamin but all other herbal, alternative and food supplements (eg, PC-Spes, Saw Palmetto, St John’s Wort) must be discontinued before enrollment into the study.
d) Ketoconazole must be discontinued 4 weeks prior to starting study therapy (Protocol Section 5.5.1).
e) Anti-androgens should be discontinued prior to starting study therapy. Subjects with a history of response to an anti-androgen and subsequent progression while on that anti-androgen should be assessed for anti-androgen withdrawal response for 4 weeks. Observation for anti-androgen withdrawal response is not necessary
for subjects who have never responded to anti-androgens.
f) Bisphosphonates must not be initiated within 28 days prior to starting study therapy.
g) QT prolonging agents strongly associated with torsade de pointes (Section 5.5.1).
6) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated.
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method