Clinical trial · Interventional
Dovitinib(TKI258) in Patients With Castration-resistant Prostate Cancer
A Phase II Study of TKI258 in Patients With Castration-resistant Prostate Cancer
NCT01741116CI-TRIAL-00050175completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKI258 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TKI258, inhibitor of RTKs
- description
- Intervention: TKI258 Investigational drug, TKI258, will be administered to all of the patients after enrollments. Treatment will initially be administered as 28-day cycles as follows: \- Daily 500mg of TKI258 will be self-administered orally by the patient for 5 days, followed by 2 days of treatment off.
- interventionNames
- Drug: TKI258
Primary outcomes (1)
- measure
- 16 week progression free survival rate
- timeFrame
- Week 16
- description
- disease progression defined as either the appearance of new lesions or unidimensional tumor measurements increasing \>20% or symptomatic progression
Secondary outcomes (1)
- measure
- Overall response rate
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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 ULN\<serum creatinine \< 3 x ULN, if calculated creatinine clearance (CrCl) is ≥ 30 mL/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
References
Publications (3)
- BACKGROUNDDorkin TJ, Robinson MC, Marsh C, Bjartell A, Neal DE, Leung HY. FGF8 over-expression in prostate cancer is associated with decreased patient survival and persists in androgen independent disease. Oncogene. 1999 Apr 29;18(17):2755-61. doi: 10.1038/sj.onc.1202624. PMID 10348350
- BACKGROUNDGnanapragasam VJ, Robinson MC, Marsh C, Robson CN, Hamdy FC, Leung HY. FGF8 isoform b expression in human prostate cancer. Br J Cancer. 2003 May 6;88(9):1432-8. doi: 10.1038/sj.bjc.6600875. PMID 12778074
- BACKGROUNDHeer R, Douglas D, Mathers ME, Robson CN, Leung HY. Fibroblast growth factor 17 is over-expressed in human prostate cancer. J Pathol. 2004 Dec;204(5):578-86. doi: 10.1002/path.1668. PMID 15538740