Solid Tumors
Conditions
Keywords
solid tumors, TKI258, Dovitinib, fulvestrant, cancers with a mass, bulky tumor, nodule, lump, cancer, solid malignancies
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.
Interventions
DRUGdovitinib
Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.
DRUGfulvestrant
Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events of Grades 3 and 4 Severity | Until the last patient discontinued dovitinib up to 30 months | 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. |
Countries
Austria, Belgium, Denmark, Italy, Japan, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dovitinib 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). | 10 |
| Dovitinib + Fulvestrant 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. | 2 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Progressive disease | 4 | 0 |
| Overall Study | Study terminated by sponsor | 2 | 1 |
Baseline characteristics
| Characteristic | Dovitinib | Dovitinib + Fulvestrant | Total |
|---|---|---|---|
| Age, Continuous | 60.3 Years STANDARD_DEVIATION 10.55 | 72.0 Years STANDARD_DEVIATION 14.14 | 62.3 Years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 0 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 2 / 2 |
| serious Total, serious adverse events | 4 / 10 | 2 / 2 |
Outcome results
Primary
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.
Time frame: Until the last patient discontinued dovitinib up to 30 months
Population: Safety set: the Safety set included all patients who received at least one dose of study medication. Safety set was identical to Full Analysis Set for this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Injury, poisoning and procedural complications | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Endocrine disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Investigations | 2 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Cardiac disorders | 2 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Metabolism and nutrition Disorders | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Eye disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Musculoskeletal and connective tissue disorders | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Gastrointestinal disorders | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Neoplasms benign, malignant & Unspecified | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Blood and lymphatic system disorders | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Nervous system Disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | General disorders & administration site conditions | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Psychiatric disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Ear and Labyrinth disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Skin and subcutaneous tissue disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Infections and Infestations | 1 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Vascular disorders | 0 Participants |
| Dovitinib | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Any Primary system organ class | 6 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Vascular disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Psychiatric disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Any Primary system organ class | 2 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Blood and lymphatic system disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Cardiac disorders | 1 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Ear and Labyrinth disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Endocrine disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Gastrointestinal disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | General disorders & administration site conditions | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Infections and Infestations | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Injury, poisoning and procedural complications | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Investigations | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Metabolism and nutrition Disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Musculoskeletal and connective tissue disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Neoplasms benign, malignant & Unspecified | 1 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Nervous system Disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Skin and subcutaneous tissue disorders | 0 Participants |
| Dovitinib + Fulvestrant | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Eye disorders | 0 Participants |