Phase I Dose Escalating Study of TKI258

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471548
• Other study ID #: CTKI258A1101
• Status: Completed
• Phase: Phase 1
• Start date: September 2008
• Est. completion date: May 2012

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• TKI258

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Hidaka	Saitama
Japan	Novartis Investigative Site	Takatsuki	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of TKI258		30 days
Secondary	Antineoplastic activity based on the RECIST criteria		22 months

External Links

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