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

NCT01421004 | Completed Phase 1

• 1 other identifier: CTKI258A2128
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Advanced Solid Tumors; Excluding Breast Cancer

Keywords

cancer; tumors; phase I; crossover; bioequivalence

Outcome Measures

Primary Outcomes (1)

• 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

  9 days

Secondary Outcomes (2)

• Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer

  up to 30 days after the last dose of study drug

• Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer

  Every 8 weeks until progression of disease

Study Arms (2)

500 mg FMI capsule + 250 mg FMI tablet

EXPERIMENTAL

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

Drug: TKI258

500 mg TKI258 FMI capsule +250 mg FMI tablet

EXPERIMENTAL

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

Drug: TKI258

Interventions

TKI258 DRUG

Also known as: dovitinib

500 mg FMI capsule + 250 mg FMI tablet; 500 mg TKI258 FMI capsule +250 mg FMI tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG performance status (PS) 0, 1 or 2
• Patients must meet protocol-specified laboratory values

You may not qualify if:

• Patients with brain metastases
• 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
• Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
• Female patients who are pregnant, breast feeding
• Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

City of Hope National Medical Center SC-2

Duarte, California, 91010-3000, United States

Location

University of California at Los Angeles UCLA LeConte Location

Los Angeles, California, 90095, United States

Location

University of California San Francisco UCSF (SC)

San Francisco, California, 94101, United States

Location

Florida Cancer Specialists Sarasota Office

Fort Myers, Florida, 33901, United States

Location

Rush University Medical Center Rush 3

Chicago, Illinois, 60612, United States

Location

Washington University School of Medicine SC

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center Montefiore Medical Center (SC)

The Bronx, New York, 10467, United States

Location

University of Oklahoma Health Sciences Center OUHSC - SC

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232-1305, United States

Location

Sarah Cannon Research Institute Sarah Cannon Research (SC)

Nashville, Tennessee, 37203, United States

Location

Sammons Cancer Center - Texas Oncology SC-2

Dallas, Texas, 78246, United States

Location

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

San Antonio, Texas, 78229, United States

Location

University of Utah / Huntsman Cancer Institute Huntsman

Salt Lake City, Utah, 84112, United States

Location

University of Wisconsin Univ Wisc

Madison, Wisconsin, 53792, United States

Location

Related Links

• Results for CTKI258A2128 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartitis Pharmaceuticals

  Novartitis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 22, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 21, 2020

Record last verified: 2015-01

Locations

US (14)