Myeloproliferative Neoplasms Clinical Trial

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

Summary

The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and were benefiting from the treatment as judged by the investigator

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Full Description

This was a multi-center, open label, single-arm, phase IV study to better characterize the long-term safety of nilotinib in patients treated in Novartis-sponsored studies and who benefited from treatment with nilotinib.

Patients who were enrolled in Novartis-sponsored nilotinib studies, had benefitted from treatment with nilotinib and fulfilled all requirements in the parent study could be enrolled into the current roll-over study.

There was no sample size estimation carried out for this study.

Patients returned to the study center on a quarterly basis (12 weeks ± 1 week) for scheduled visit. Adverse Events (AEs) (non-serious and serious AEs), clinical benefit assessment by investigator and study medication dispensing information were collected.

The original protocol of the current roll-over study was designed to provide continuation of treatment with nilotinib for patients enrolled in nilotinib studies. Therefore, the original protocol did not require AEs (non-serious and serious AEs) to be collected into the clinical database and only required serious adverse events (SAEs) to be collected in the Novartis safety database throughout the study duration.

The scheduled visit frequency was annually.

However, feedback from health authorities stated that all AEs should be collected. To account for this, the protocol was amended in 2016 (Protocol amendment 3 (PA 3)), with the primary objective changed to assess long-term safety of nilotinib. Consequently, PA 3 started to require all AEs (non-serious and serious AEs) to be entered into the clinical database, in addition to the continued SAE collection into the Novartis safety database. At the same time, the scheduled visit frequency was increased from annually to quarterly, and the protocol was also amended to require an investigator assessment of clinical benefit for patients.

View Eligibility Criteria

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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 4

Estimated Enrollment:

57

Study ID:

NCT01735955

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 32 Locations for this study

See Locations Near You

Novartis Investigative Site
Albany New York, 12208, United States
Novartis Investigative Site
Houston Texas, 77030, United States
Novartis Investigative Site
Vienna , A 109, Austria
Novartis Investigative Site
Vancouver British Columbia, V5Z 4, Canada
Novartis Investigative Site
Halifax Nova Scotia, B3H 1, Canada
Novartis Investigative Site
Hamilton Ontario, L8V 5, Canada
Novartis Investigative Site
Toronto Ontario, M5G1X, Canada
Novartis Investigative Site
Lille , 59000, France
Novartis Investigative Site
Paris , 75571, France
Novartis Investigative Site
Hong Kong SAR , , Hong Kong
Novartis Investigative Site
Budapest , 1062, Hungary
Novartis Investigative Site
Budapest , 1097, Hungary
Novartis Investigative Site
Haifa , 31096, Israel
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Genova GE, 16147, Italy
Novartis Investigative Site
Modena MO, 41124, Italy
Novartis Investigative Site
Roma RM, 00161, Italy
Novartis Investigative Site
Candiolo TO, 10060, Italy
Novartis Investigative Site
Suwon Gyeonggi-do, 44338, Korea, Republic of
Novartis Investigative Site
Seoul Korea, 05505, Korea, Republic of
Novartis Investigative Site
Seoul , 06351, Korea, Republic of
Novartis Investigative Site
Amsterdam , 1081 , Netherlands
Novartis Investigative Site
Leiden , 2300 , Netherlands
Novartis Investigative Site
Moscow , 11719, Russian Federation
Novartis Investigative Site
Singapore , 11922, Singapore
Novartis Investigative Site
Singapore , 16960, Singapore
Novartis Investigative Site
Bratislava , 833 1, Slovakia
Novartis Investigative Site
Barcelona , 08041, Spain
Novartis Investigative Site
Malmö , SE-20, Sweden
Novartis Investigative Site
Cambridge London, CB2 2, United Kingdom
Novartis Investigative Site
London , SW3 6, United Kingdom
Novartis Investigative Site
Manchester , M20 4, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 4

Estimated Enrollment:

57

Study ID:

NCT01735955

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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