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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


Phase 4
N/A
N/A
Open (Enrolling)
Both
GIST and CML

Thank you

Trial Information

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


Inclusion Criteria:



-Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development &
Medical Affairs 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 demonstrated compliance, as assessed by the
investigator, with the parent study protocol requirements -Willingness and ability to
comply with scheduled visits, treatment plans and any other study procedures -Written
informed consent obtained prior to enrolling in roll-over study

Exclusion Criteria:

- Patient has been permanently discontinued from nilotinib 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 patient is
still receiving combination therapy -Patients who are currently receiving treatment with
any medications that have the potential to prolong the QT interval or inducing Torsade de
Pointes and the treatment cannot be either safely discontinued at least one week prior to
nilotinib treatment or switched to a different medication prior to start of nilotinib
treatment and for the duration of the study -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. -Women of child-bearing
potential, defined as all women physiologically capable of becoming pregnant, unless they
are using highly effective methods of contraception during the study and for 30 days after
the final dose of nilotinib. Male patients must use highly effective contraception during
the study and for 30 days after the final dose of nilotinib.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients receiving nilotinib

Outcome Description:

To allow continued use of nilotinib to patients receiving nilotinib in a Novartis-sponsored Oncology CD&MA study which has reached its objectives and who are benefiting from treatment with nilotinib.

Outcome Time Frame:

Until no patients are left on study up to 10 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2409

NCT ID:

NCT01735955

Start Date:

March 2013

Completion Date:

March 2023

Related Keywords:

  • GIST and CML
  • Tasigna
  • CML
  • GIST
  • nilotinib

Name

Location

US Oncology Central MonitoringDallas, Texas  75246
New York Oncology Hematology, P.C. SCTroy, New York  12180
New York Oncology Hematology, P.C. SC - 2Troy, New York  12180
MD Anderson Cancer Center/University of Texas SC - 5Houston, Texas  77030-4009