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

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)

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60 participants in 2 patient groups

TKI258 - bioavailability

Experimental group

Treatment:

Drug: TKI258 (dovitinib)

TKI258 - food

Experimental group

Treatment:

Drug: TKI258 (dovitinib)