Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

• ClinicalTrials.gov Identifier: NCT01735955
• Recruitment Status: Active, not recruiting
• First Posted: November 28, 2012
• Last Update Posted: October 6, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: November 14, 2012
• First Posted Date: November 28, 2012
• Last Update Posted Date: October 6, 2022
• Actual Study Start Date: March 29, 2013
• Estimated Primary Completion Date: April 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2022)

Percentage of participants with Adverse events and serious adverse events [ Time Frame: Until no patients are left on study up to 10 years ]

Percentage of participants with Adverse events and serious adverse events

Original Primary Outcome Measures (submitted: November 21, 2012)

Number of patients receiving [ Time Frame: Until no patients are left on study up to 10 years ]

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.

Current Secondary Outcome Measures (submitted: October 4, 2022)

Percentage of participants with clinical benefit [ Time Frame: Until no patients are left on study up to 10 years ]

Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits

Original Secondary Outcome Measures (submitted: November 21, 2012)

• Frequency of serious adverse events [ Time Frame: Until no patients are left on study up to 10 years ]
  To collect long term data on serious adverse events.
• Nature of serious adverse events [ Time Frame: Until no patients are left on study up to 10 years ]
  To collect long term data on nature serious adverse events.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
• Official Title: 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
• Brief Summary: The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: GIST and CML

Intervention

Drug: Nilotinib

Nilotinib can be provided as 200 mg and 150 mg hard gelatin capsules for oral use. Additional strengths of nilotinib can be provided if specified in the parent protocol. The starting dose of nilotinib should be the same as the last dose that was given in the parent nilotinib study. After this, the dose of nilotinib is based on the investigator's judgment.

Other Name: AMN107

Study Arms

Experimental: Nilotinib

All participants who were on nilotinib treatment in a Novartis-sponsored study and were benefiting from the treatment as judged by the investigator, will receive nilotinib at the starting dose of the parent study. After this, the dose of nilotinib is based on the investigator's judgment.

Intervention: Drug: Nilotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 30, 2021): 57
• Original Estimated Enrollment (submitted: November 21, 2012): 300
• Estimated Study Completion Date: April 28, 2023
• Estimated Primary Completion Date: April 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Canada, France, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Russian Federation, Singapore, Slovakia, Spain, Sweden, United Kingdom, United States
• Removed Location Countries: Argentina, China, Germany, Thailand

Administrative Information

• NCT Number: NCT01735955
• Other Study ID Numbers: CAMN107A2409; 2012-003902-28 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: October 2022