Conditions: Solid Tumors
Keywords: solid tumors TKI258 Dovitinib fulvestrant cancers with a mass bulky tumor nodule lump cancer solid malignancies
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.

Detailed description:

Arms:
arm 1: Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). arm 2: Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.

Interventions: intervention 1: dovitinib intervention 2: fulvestrant
Intervention descriptions: intervention 1: Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally. intervention 2: Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.

Protocol document: