Dovitinib(TKI258) in Patients With Castration-resistant Prostate Cancer

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to evaluate efficacy and safety of Dovitinib(TKI258) in patients with castration resistant prostate cancer after failure of docetaxel-based chemotherapy. Further correlative study for metabolic response using PET image and change in serum fibroblast growth factor 23(FGF23) will be conducted.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean Cancer Study Group

Criteria

Inclusion Criteria:

• Patients with histologically confirmed progressive metastatic androgen-independent adenocarcinoma of the prostate with radiographic evidence of disease.

• No more than two previous cytotoxic chemotherapy

• Castration level of testosterone (< 50 ng/dl) achieved by orchiectomy or gonadotropin-releasing hormone(GnRH) agonist

• Eastern Cooperative Oncology Group(ECOG) performance status 0 - 2

• Finished any study drug or chemotherapy earlier than 4 weeks before the first administration of the study drug.

• Age ≥ 20 years old

• Patients must have the following laboratory values:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelets ≥ 75 x 109/L

• Hemoglobin (Hgb) > 8 g/dL

• Serum total bilirubin: ≤ 1.5 x ULN

• alanine transaminase(ALT) and aspartate aminotransferase(AST) ≤ 2.0 x upper limit of normal(ULN) with or without liver metastases

• Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN or 1.5 x ULNmL/min using the Cockcroft-Gault equation, see formula below:

CrCl = [140-age (years)] x weight (kg) / [72 x serum Cr (mg/dL)] (if patient is female multiply the above by 0.85)

• Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria

• Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases

• Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or non-melanomatous skin cancer