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A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors, Excluding Breast Cancer

Thank you

Trial Information

A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors


Inclusion Criteria:



1. Patients with a histopathologically or cytopathologically confirmed diagnosis of an
advanced solid tumor, excluding breast cancer, who have progressed despite standard
therapy, or for which no standard therapy exists

2. ECOG performance status (PS) 0, 1 or 2

3. Patients must meet protocol-specified laboratory values

Exclusion Criteria:

1. Patients with brain metastases

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

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

4. Patients who are expected to receive any prohibited medications during the
bioequivalence phase of the study

5. Female patients who are pregnant, breast feeding

6. Fertile male or women of child-bearing potential not willing to use two highly
effective methods of contraception

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:

Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax

Outcome Time Frame:

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:

CTKI258A2128

NCT ID:

NCT01421004

Start Date:

December 2011

Completion Date:

January 2013

Related Keywords:

  • Advanced Solid Tumors
  • Excluding Breast Cancer
  • cancer
  • tumors
  • phase I
  • crossover
  • bioequivalence
  • Breast Neoplasms
  • Neoplasms

Name

Location

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) San Antonio, Texas  78229
UCLA/ University of California Los Angeles UCLA LeConte Location Los Angeles, California  90095
University of Wisconsin Univ Wisc Madison, Wisconsin  53792
University of Utah / Huntsman Cancer Institute Huntsman Salt Lake City, Utah  84103
City of Hope National Medical Center SC-2 Duarte, California  91010-3000
University of California San Francisco UCSF (SC) San Francisco, California  
Florida Cancer Specialists Sarasota Office Fort Myers, Florida  33901
Rush University Medical Center Rush 3 Chicago, Illinois  60612
Washington University School Of Medicine-Siteman Cancer Ctr SC St. Louis, Missouri  63110
Montefiore Medical Center Montefiore Medical Center (SC) Bronx, New York  10467
University of Oklahoma Health Sciences Center OUHSC - SC Oklahoma City, Oklahoma  73104
University of Pittsburgh University of Pittsburgh (SC) Pittsburgh, Pennsylvania  15232-1305
Sarah Cannon Research Institute Sarah Cannon Research (SC) Nashville, Tennessee  37203
Sammons Cancer Center Sammons Cancer Center SC-2 Dallas, Texas  78246