A study to evaluate long-term safety of the experimental drug TKI258 in patients with solid tumors who received TKI258 in another study that has completed its primary objective, and who continue to benefit from TKI258 treatment

Phase 1

• Conditions: Patients with solid tumors; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000368-17-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-12
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

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 dovitinib alone or in combination with fulvestrant within a Novartis study which has fulfilled the requirements for the primary objective, and in the opinion of the investigator, are benefiting from treatment, which includes dovitinib
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified