Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01735955 |
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Recruitment Status :
Active, not recruiting
First Posted : November 28, 2012
Last Update Posted : May 7, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| GIST and CML | Drug: AMN107 | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 29, 2013 |
| Estimated Primary Completion Date : | April 28, 2023 |
| Estimated Study Completion Date : | April 28, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: AMN107 (nilotinib)
AMN107
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Drug: AMN107
AMN107 (nilotinib) |
- Number of patients receiving nilotinib [ 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735955
| United States, New York | |
| New York Oncology Hematology SC - 2 | |
| Albany, New York, United States, 12208 | |
| United States, Texas | |
| University of Texas/MD Anderson Cancer Center SC - 5 | |
| Houston, Texas, United States, 77030-4009 | |
| Austria | |
| Novartis Investigative Site | |
| Vienna, Austria, A-1090 | |
| Canada, British Columbia | |
| Novartis Investigative Site | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Nova Scotia | |
| Novartis Investigative Site | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G1X5 | |
| France | |
| Novartis Investigative Site | |
| Lille, France, 59000 | |
| Novartis Investigative Site | |
| Paris, France, 75571 | |
| Hong Kong | |
| Novartis Investigative Site | |
| Hong Kong SAR, Hong Kong | |
| Hungary | |
| Novartis Investigative Site | |
| Budapest, Hungary, 1062 | |
| Novartis Investigative Site | |
| Budapest, Hungary, 1097 | |
| Israel | |
| Novartis Investigative Site | |
| Haifa, Israel, 3525408 | |
| Italy | |
| Novartis Investigative Site | |
| Bologna, BO, Italy, 40138 | |
| Novartis Investigative Site | |
| Genova, GE, Italy, 16147 | |
| Novartis Investigative Site | |
| Modena, MO, Italy, 41124 | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00161 | |
| Novartis Investigative Site | |
| Candiolo, TO, Italy, 10060 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Suwon, Gyeonggi-do, Korea, Republic of, 443380 | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 05505 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 06351 | |
| Netherlands | |
| Novartis Investigative Site | |
| Amsterdam, Netherlands, 1081 HV | |
| Novartis Investigative Site | |
| Leiden, Netherlands, 2300 RC | |
| Russian Federation | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 117198 | |
| Singapore | |
| Novartis Investigative Site | |
| Singapore, Singapore, 119228 | |
| Novartis Investigative Site | |
| Singapore, Singapore, 169608 | |
| Slovakia | |
| Novartis Investigative Site | |
| Bratislava, Slovakia, 833 10 | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Spain, 08041 | |
| Sweden | |
| Novartis Investigative Site | |
| Malmö, Sweden, SE-205 02 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Cambridge, London, United Kingdom, CB2 2QQ | |
| Novartis Investigative Site | |
| London, United Kingdom, SW3 6JJ | |
| Novartis Investigative Site | |
| Manchester, United Kingdom, M20 4BX | |
| Novartis Investigative Site | |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01735955 |
| Other Study ID Numbers: |
CAMN107A2409 2012-003902-28 ( EudraCT Number ) |
| First Posted: | November 28, 2012 Key Record Dates |
| Last Update Posted: | May 7, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Tasigna CML GIST nilotinib |