A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined withDasatinib to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer
- Conditions
- Castration-Resistant Prostate CancerC04.588.945.440.770
- Registration Number
- RBR-36w269
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruitment completed
- Sex
- Male
- Target Recruitment
- Not specified
Subjects must have signed an informed consent document stating that they
understand the investigational nature of the proposed treatment.
History of histologically diagnosed prostate cancer.
Evidence of metastatic disease by any 1 of the following modalities: CT scan,
MRI, bone scan, or skeletal survey.
Evidence of progression, as defined by 1 of the following:
Rising PSA values at least 1 week apart with the final value being >= 2 ng/mL,or
Progression of measurable nodal or visceral disease:
Nodal lesions must be >= 20 mm
Visceral lesions must be measurable per RECIST criteria, or
Two or more new lesions appearing on a bone scan compared with a prior
scan, or
Local recurrence in the prostate or prostate bed.
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).
ECOG Performance Status 0 - 2.
At least 4 weeks since major surgery, radiotherapy, and an investigational agent.
At least 8 weeks since radioisotope therapy (eg, Strontium-89, Samarium-153 or
similar agents).
Recovery from local primary therapy of surgery or radiation.
Required initial laboratory values:
WBC >= 3,000/mm3.
ANC >= 1,500/mm3.
Platelet count >= 100,000/mm3.
Creatinine <= 1.5 x upper limits of normal.
Bilirubin <= upper limit of normal (does not apply for subjects with Gilbert’s
Disease).
SGOT (AST) <= 2.5 x upper limits of normal.
SGPT (ALT) <= 2.5 x upper limits of normal.
Men only, at least 18 years old.
Women.
Sexually active fertile men not using effective birth control if their partners are WOCBP.
Subjects with active brain metastases or leptomeningeal metastases are excluded
from this clinical trial.
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.
Pleural or pericardial effusion of any CTC grade.
Peripheral neuropathy CTC Grade >= 2.
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.
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.
HIV-positive subjects receiving combination anti-retroviral therapy.
History of allergic reactions attributed to compounds of similar chemical or
biologic composition to the investigational agents.
Subjects may not be receiving any other investigational agents for the treatment of
prostate cancer.
No prior cytotoxic chemotherapy in the metastatic setting, with the exception of
estramustine.
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.
Ketoconazole must be discontinued 4 weeks prior to starting study therapy.
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.
Bisphosphonates must not be initiated within 28 days prior to starting study
therapy.
QT prolonging agents strongly associated with torsade de pointes.
Prisoners or subjects who are involuntarily incarcerated.
Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method