Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

NCT01155713 | Completed Phase 1

• 1 other identifier: CTKI258A2116
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.

Conditions

Neoplasm; Cancer; Tumors

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

  relative bioavailability (9 days)

• Determine the effect of food on the bioavailability of TKI258

  food effect (22 days)

Secondary Outcomes (2)

• Characterize the safety and tolerability of TKI258, including acute and chronic toxicities.

  Up to 28 days after the last dose of study drug

• Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors.

  Every 8 weeks until progression of disease

Study Arms (2)

Arm 1 - TKI258 - bioavailability

EXPERIMENTAL

Drug: TKI258

TKI258 - food effect

EXPERIMENTAL

Drug: TKI258

Interventions

TKI258 DRUG

Also known as: Dovitinib

Arm 1 - TKI258 - bioavailability; TKI258 - food effect

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

Scottsdale, Arizona, 85258, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Sarah Cannon Research Institute Sarah Cannon Research Instit

Nashville, Tennessee, 37203, United States

Location

University of Utah / Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Links

• Results for CTKI258A2116 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

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: June 30, 2010
• First Posted: July 2, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 21, 2020

Record last verified: 2016-05

Locations

US (4)