Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Docetaxel; Prednisone

Criteria

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.