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

A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258, and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01030055

Enrollment

Registered

2009-12-11

Start date

2010-02-28

Completion date

2012-06-30

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Neoplasms, Tumors

Keywords

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

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

Interventions

DRUGTKI258 (dovitinib)

bioavailability (anhydrate capsules) food (monohydrae capsules)

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with an advanced solid tumor, except breast cancer,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

Exclusion criteria

* 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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Determine the relative bioavailability of the final market image form of TKI258 (monohydrate capsules) as compared to the clinical service form of TKI258 (anhydrate capsules)	9 days
Determine the effect of food on the bioavailability of TKI258	22 days

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026