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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


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of TKI258

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A1101

NCT ID:

NCT01471548

Start Date:

September 2008

Completion Date:

May 2012

Related Keywords:

  • Advanced Solid Tumors
  • tumor
  • cancer
  • phase1
  • TKI258

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