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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222142

Enrollment

Registered

2013-07-10

Start date

2013-06-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal stromal tumors

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
long-term safety of nilotinib	—

Countries

none

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026