Phase I Dose Escalating Study of TKI258

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TKI258

• Registration Number: NCT01471548
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-16
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Deemed otherwise unsuitable by the investigator

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TKI258	TKI258	dose escalation

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of TKI258	30 days

Secondary Outcome Measures

Name	Time	Method
Antineoplastic activity based on the RECIST criteria	22 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Hidaka, Saitama, Japan