Patients with solid tumours MedDRA version: 16.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: dovitinib
Product Code: TKI258
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dovitinib
CAS Number: 915769-50-5
Current Sponsor code: TKI258
Other descriptive name: NA
Concentra
Sponsors
NOVARTIS FARMA S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: 1. Patients who give a written informed consent, obtained according to local guidelines 2. Patients with solid tumors, who are currently receiving treatment with single agent dovitinib within a Novartis study which has fulfilled the requirements for the primary objective, and in the opinion of the investigator, would benefit from continued treatment 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements 4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria: 1. Concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol 2. Patient currently has unresolved toxicities for which study drug dosing has been interrupted in the parent study (patients meeting allother eligibility criteria may be enrolled once toxicities have resolved to allow study drug dosing to resume) 3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 30 days after the last dose of study medication. Highly effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment • Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject. • Combination the following (a+b): a. Placement of an intrauterine device (IUD) or intrauterine system (IUS) b. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository Oral, implantable, or injectable hormone contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study Women of child-bearing potential (sexually mature women) who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative urine or serum pregnancy test = 14 days prior to starting study drug for the current study 5. Fertile males not willing to use contraception. Fertile males must use condom with spermicide. Highly effective contraception, as defined above, must be used by both sexes (male patients and their female partners) during study treatment and for 90 days after the last dose of study medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate long-term safety and tolerability of dovitinib in patients with solid tumors, who are currently receiving treatment with single agent dovitinib within a Novartis sponsored study which has fulfilled the requirements for the primary objective;Secondary Objective: Not applicable;Primary end point(s): Incidence and severity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified; clinical laboratory tests, physical examinations, vital signs, ECGs, and cardiac imaging;Timepoint(s) of evaluation of this end point: Patients will be treated with dovitinib until unacceptable toxicity is experienced that precludes further treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the investigator, initiation of new anticancer therapy, and/or discontinuation for any other reason. Safety monitoring will be conducted as per visit schedule. AE and SAE collection will be continuous. Tumor assessments will be performed per standard of care but no less than once every 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Austria, Belgium, Denmark, France, Italy, Japan, Netherlands, Spain, Switzerland, United States
Contacts
Public ContactDrug Regulatory Affairs
NOVARTIS FARMA S.p.A.
Outcome results
None listed