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

NCT01030055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-21

No results posted yet for this study

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

Interventions

DRUG

TKI258 (dovitinib)

bioavailability (anhydrate capsules) food (monohydrae capsules)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030055 on ClinicalTrials.gov