臨床研究等提出・公開システム

An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartissponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment

An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartis-sponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment

15

The mean (SD) age was 64.5(13.39) years. 53.3% (8/15 patients) were male. 100% (15/15 patients) were Japanese.

There was no screening period for this study. At the enrolment visit the participant was consented to the study and eligible participants started their treatment with nilotinib. The parents nilotinib studies are CAMN107G2301 and CAMN107D1201. The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg. A total of 15 participants were enrolled of which 2 (13.3%) participants completed the treatment and 13 (86.7%) participants discontinued the treatment. The main reason for discontinuation was disease progression (9 participants, 60%), followed by AEs (2 participants, 13.3%). 1(6.7%) patient each was discontinued due to death and withdrawal of consent.

A total of 13 (86.7%) participants had adverse events. Treatment related AEs were reported in 8 (53.3%) participants. SAEs in 9 (60.0%) participants. A fatal SAE (death) was reported in 1 (6.7%) participant and no fetal SAEs related to treatment were reported. The SAEs experienced by PT were Acute myocardial infarction in 2 (13.33%) participants, 1 (6.67%) participant each experienced cataract, Ileus, small intestinal haemorrhage, dehydration, tumor haemorrhage, cerebellar infarction, cerebrovascular insufficiency and thrombotic cerebral infarction. The most common AEs (not including SAEs) experienced by PT (>= 20%, 3 participants) were Nasopharyngitis (33.33%), Oedema peripheral (26.67%), influenza (20.00%) and pain in extremity (20.00%).

Primary outcome measures were number of participants with AEs and SAEs, and results are described above. No secondary outcome measures were defined.

The nature of AEs did not tend to be different from previous nilotinib studies. No new safety signals for nilotinib were identified in this study. The safety of nilotinib is consistent with the known safety profile of nilotinib.

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

completed

June. 07, 2013

Interventional

open label, multi center

treatment purpose

2

- Patient is currently enrolled in a Novartis- sponsored clinical study receiving nilotinib and has fulfilled all their requirements in the parent study.
- Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator.

- Patient has been permanently discontinued from nilotinib study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
- Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and is still receiving combination therapy.
- Pregnant or nursing (lactating) women

Both

Gastrointestinal stromal tumors

Nilotinib administered orally at total daily dose of <=800 mg

long-term safety of nilotinib

May. 09, 2013