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

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Novartis

Status and phase

Completed
Phase 1

Conditions

Tumors
Neoplasms
Cancer

Treatments

Drug: TKI258 (dovitinib)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030055
CTKI258A2112

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

60 participants in 2 patient groups

TKI258 - bioavailability
Experimental group
Treatment:
Drug: TKI258 (dovitinib)
TKI258 - food
Experimental group
Treatment:
Drug: TKI258 (dovitinib)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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