An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

NCT02116803 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CTKI258A2X01B2014-000368-17
• Study Type: interventional
• Target: 12
• Locations: 7 countries
• Sites: 9

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.

Conditions

Solid Tumors

Keywords

solid tumors; TKI258; Dovitinib; fulvestrant; cancers with a mass; bulky tumor; nodule; lump; cancer; solid malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events of Grades 3 and 4 Severity

  Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.

  Until the last patient discontinued dovitinib up to 30 months

Study Arms (2)

dovitinib

EXPERIMENTAL

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).

Drug: dovitinib

dovitinib + fulvestrant

EXPERIMENTAL

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.

Drug: dovitinib; Drug: fulvestrant

Interventions

dovitinib DRUG

Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.

Also known as: TKI258

dovitinib; dovitinib + fulvestrant

fulvestrant DRUG

Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.

dovitinib + fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
• patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment.
• patient had demonstated compliance
• patient had given written informed consent.

You may not qualify if:

• patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
• patient was pregnant or nursing at the time of entry
• women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Las Vegas, Nevada, 89169, United States

Location

Novartis Investigative Site

The Bronx, New York, 10467-2490, United States

Location

Novartis Investigative Site

Salzburg, 5020, Austria

Location

Novartis Investigative Site

Wilrijk, 2610, Belgium

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Torino, TO, 10153, Italy

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one; Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: May 28, 2014
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: March 1, 2018
• Results First Posted: February 1, 2018

Record last verified: 2018-01

Locations

DK (1); US (2); AU (1); ES (1); BE (1); IT (2); JP (1)