Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
NCT ID: NCT01421004
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
166 participants
INTERVENTIONAL
2011-12-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of TKI258 in Advanced/Metastatic Melanoma Subjects
NCT00303251
Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies
NCT00669097
Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.
NCT01248858
A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
NCT02937675
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
NCT01379534
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
500 mg FMI capsule + 250 mg FMI tablet
BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet
TKI258
500 mg TKI258 FMI capsule +250 mg FMI tablet
BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule
TKI258
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TKI258
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ECOG performance status (PS) 0, 1 or 2
3. Patients must meet protocol-specified laboratory values
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartitis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartitis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope National Medical Center SC-2
Duarte, California, United States
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States
University of California San Francisco UCSF (SC)
San Francisco, California, United States
Florida Cancer Specialists Sarasota Office
Fort Myers, Florida, United States
Rush University Medical Center Rush 3
Chicago, Illinois, United States
Washington University School of Medicine SC
St Louis, Missouri, United States
Montefiore Medical Center Montefiore Medical Center (SC)
The Bronx, New York, United States
University of Oklahoma Health Sciences Center OUHSC - SC
Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute Sarah Cannon Research (SC)
Nashville, Tennessee, United States
Sammons Cancer Center - Texas Oncology SC-2
Dallas, Texas, United States
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, United States
University of Wisconsin Univ Wisc
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CTKI258A2128 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTKI258A2128
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.