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

NCT01741116 | Completed Phase 2 DMC

• 2 other identifiers: KCSG-GU11-05GU11-05
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

castration-resistant prostate cancer; TKI258; FGF23

Outcome Measures

Primary Outcomes (1)

• 16 week progression free survival rate

  disease progression defined as either the appearance of new lesions or unidimensional tumor measurements increasing \>20% or symptomatic progression

  Week 16

Secondary Outcomes (1)

• Overall response rate

  up to 24 months

Other Outcomes (3)

• Overall survival

  up to 36 months

• Serum FGF23

  2 months after chemotherapy

• PET-CT

  2 months after chemotherapy

Study Arms (1)

TKI258, inhibitor of RTKs

EXPERIMENTAL

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.

Drug: TKI258

Interventions

TKI258 DRUG

Investigational treatment refers to TKI258 in this study Until Progression, unacceptable toxicity, withdrawal

Also known as: Dovitinib

TKI258, inhibitor of RTKs

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Cancer Study Group: lead

Study Sites (2)

Korean Cancer Study Group

Seoul, Chongro-ku, 110999, South Korea

Location

Korea University Anam Hospital

Seoul, Seongbuk-gu, Inchon-ro, 136-705, South Korea

Location

Related Publications (3)

• Dorkin 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 BACKGROUND

• Gnanapragasam 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 BACKGROUND

• Heer 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 BACKGROUND

MeSH Terms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Study Officials

• Kyong Hwa Park, MD, phD

  Korea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Korean Cancer Study Group

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2016
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

KR (2)