Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatments placebo, dasatinib, docetaxel, prednisone
Phase phase 3
Target BCR-ABL
Sponsor Bristol-Myers Squibb
Start date October 2008
End date August 2012
Trial size 1930 participants
Trial identifier NCT00744497, 2008-000701-11, CA180-227

Summary

The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
placebo
docetaxel
prednisone
(Active Comparator)
Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
dasatinib Sprycel
docetaxel
prednisone

Primary Outcomes

Measure
Overall Survival: Time From Randomization to Date of Death
time frame: From randomization to death or date of last contact (maximum reached: 45 months)

Secondary Outcomes

Measure
Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)
Time to First Skeletal-related Event (SRE)
time frame: From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)
Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline
time frame: At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)
Progression-free Survival (PFS)
time frame: From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)
Time to Prostate Specific Antigen (PSA) Progression
time frame: From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)
Percentage of Participants With a Reduction in Pain Intensity From Baseline
time frame: At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - History of histologically diagnosed prostate cancer - Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey - Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being >=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions >=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed - Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone <=50 ng/dL - Eastern Cooperative Oncology Group Performance Status of 0 to 2 - At least 4 weeks since an investigational agent prior to starting study therapy - At least 8 weeks since radioisotope therapy prior to starting study therapy - Recovery from any local therapy including surgery or radiation/radiotherapy for a minimum of 7 days prior to starting study therapy - Required initial laboratory values: white blood cell count >=3,000/mm^3; absolute neutrophil count >=1,500/mm^3; platelet count >=100,000/mm^3; creatinine level <=1.5*upper limit of normal (ULN); bilirubin <=ULN; aspartate aminotransferase <=2.5*ULN; alanine aminotransferase <=2.5*ULN. Exclusion Criteria: - Symptomatic brain metastases or leptomeningeal metastases - Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc >450 msec; ejection fraction <40%; or major conduction abnormality, unless a cardiac pacemaker is present - Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade - Peripheral neuropathy CTC Grade >=2 - Currently active second malignancy other than nonmelanoma skin cancers. Participants 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 ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - HIV infection-positive patients receiving combination antiretroviral therapy - History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents - Receipt of any other investigational agents for the treatment of prostate cancer - Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine - Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment - Ketoconazole must be discontinued 4 weeks prior to starting study therapy - Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens - Bisphosphonates must not be initiated within 28 days prior to starting study therapy - QT prolonging agents strongly associated with torsade de pointes.

Additional Information

Official title A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.