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A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasm, Cancer, Tumors

Thank you

Trial Information

A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Patients with an advanced solid tumor which has progressed despite standard therapy,
or for which no standard therapy exists

- World Health Organization (WHO) performance status ≤ 2

- Patient must meet protocol-specified laboratory values

Exclusion Criteria:

- Patients with brain cancer

- Patients who have concurrent severe and/or uncontrolled medical conditions which
could compromise participation in the study

- Patients who have not recovered from previous anti-cancer therapies

- Female patients who are pregnant, breast feeding, or not willing to use an effective
method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules)

Outcome Time Frame:

relative bioavailability (9 days)

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2116

NCT ID:

NCT01155713

Start Date:

July 2010

Completion Date:

July 2013

Related Keywords:

  • Neoplasm
  • Cancer
  • Tumors
  • Neoplasms
  • Cancer
  • Tumors
  • Administration, oral
  • Capsules
  • CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258,
  • Bioavailability,
  • Food
  • Neoplasms

Name

Location
Novartis Investigative site Nashville, Tennessee  37232
Novartis Investigative Site Durham, North Carolina  27710
Novartis Investigative Site Tucson, Arizona  85724
Novartis Investigative Site Salt Lake City, Utah  84112