Phase I Dose Escalating Study of TKI258

NCT01471548 | Completed Phase 1

• 1 other identifier: CTKI258A1101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.

Conditions

Advanced Solid Tumors

Keywords

tumor; cancer; phase1; TKI258

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of TKI258

  30 days

Secondary Outcomes (1)

• Antineoplastic activity based on the RECIST criteria

  22 months

Study Arms (1)

TKI258

EXPERIMENTAL

dose escalation

Drug: TKI258

Interventions

TKI258 DRUG

Also known as: Dovitinib

TKI258

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained prior to any screening procedures
• Advanced solid tumors
• Agreement to remaining hospitalized
• ECOG performance status of 0 or 1
• Life expectancy of at least 3 months
• Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
• Demonstrate the specific hematological /blood chemistry laboratory values

You may not qualify if:

• Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
• Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
• Patients with CNS and/or leptomeningeal disease metastases
• Presence or history of thromboembolic or cerebrovascular events
• Impaired cardiac function or clinically significant cardiac disease
• Malabsorption syndrome or uncontrolled gastrointestinal toxicities
• Patients known to be HIV- or HBV- or HCV- positive
• Patients with acute or chronic uncontrolled infection
• Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
• Patients who have been receiving anticoagulant therapy
• Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
• Patients who have been administering concomitant medication which may prolong the QTc interval
• Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
• Patients with a large volume of ascitic and/or pleural fluid which requires drainage
• Patients with any bone fractures

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Takatsuki, Osaka, 569-8686, Japan

Location

Novartis Investigative Site

Hidaka, Saitama, 350-1241, Japan

Location

Related Links

• Results for CTKI258A1101 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Neoplasms

Interventions

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 16, 2011
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 21, 2020

Record last verified: 2016-04

Locations

JP (2)