MedDataX Logo

Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors

NCT ID: NCT01421004

Last Updated: 2020-12-21

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.

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.

Advanced Solid Tumors Excluding Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cancer tumors phase I crossover bioequivalence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

TKI258

Intervention Type DRUG

500 mg TKI258 FMI capsule +250 mg FMI tablet

BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule

Group Type EXPERIMENTAL

TKI258

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TKI258

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

dovitinib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

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

Site Status

University of California at Los Angeles UCLA LeConte Location

Los Angeles, California, United States

Site Status

University of California San Francisco UCSF (SC)

San Francisco, California, United States

Site Status

Florida Cancer Specialists Sarasota Office

Fort Myers, Florida, United States

Site Status

Rush University Medical Center Rush 3

Chicago, Illinois, United States

Site Status

Washington University School of Medicine SC

St Louis, Missouri, United States

Site Status

Montefiore Medical Center Montefiore Medical Center (SC)

The Bronx, New York, United States

Site Status

University of Oklahoma Health Sciences Center OUHSC - SC

Oklahoma City, Oklahoma, United States

Site Status

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute Sarah Cannon Research (SC)

Nashville, Tennessee, United States

Site Status

Sammons Cancer Center - Texas Oncology SC-2

Dallas, Texas, United States

Site Status

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

San Antonio, Texas, United States

Site Status

University of Utah / Huntsman Cancer Institute Huntsman

Salt Lake City, Utah, United States

Site Status

University of Wisconsin Univ Wisc

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13570

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