ALK Positive Malignancies Clinical Trial
Official title:
An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib
| Verified date | June 2024 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.
| Status | Active, not recruiting |
| Enrollment | 233 |
| Est. completion date | June 9, 2025 |
| Est. primary completion date | June 9, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria: - Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment. - 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 the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness. Exclusion Criteria: - Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason. - Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent 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 serum 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 dosing and for 3 months afer stopping ceritinib treatment. - Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Auckland | |
| Australia | Novartis Investigative Site | Melbourne | Victoria |
| Belgium | Novartis Investigative Site | Leuven | |
| Brazil | Novartis Investigative Site | Barretos | Sao Paulo |
| Brazil | Novartis Investigative Site | Natal | RN |
| Brazil | Novartis Investigative Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Novartis Investigative Site | Sao Paulo | SP |
| Bulgaria | Novartis Investigative Site | Sofia | |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Changchun | Jilin |
| China | Novartis Investigative Site | Guangzhou | |
| China | Novartis Investigative Site | Guangzhou | Guangdong |
| China | Novartis Investigative Site | Guangzhou | Guangdong |
| Colombia | Novartis Investigative Site | Monteria | |
| Czechia | Novartis Investigative Site | Brno | Czech Republic |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Saint-Herblain | |
| France | Novartis Investigative Site | Strasbourg Cedex | |
| France | Novartis Investigative Site | Villejuif | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Heidelberg | |
| Germany | Novartis Investigative Site | Koeln | |
| Germany | Novartis Investigative Site | Regensburg | Bavaria |
| Germany | Novartis Investigative Site | Wuerzburg | |
| Hong Kong | Novartis Investigative Site | Hong Kong | |
| Hong Kong | Novartis Investigative Site | Shatin New Territories | |
| Italy | Novartis Investigative Site | Aviano | PN |
| Italy | Novartis Investigative Site | Bergamo | BG |
| Italy | Novartis Investigative Site | Bologna | BO |
| Italy | Novartis Investigative Site | Brescia | BS |
| Italy | Novartis Investigative Site | Meldola | FC |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Modena | MO |
| Italy | Novartis Investigative Site | Monza | MB |
| Italy | Novartis Investigative Site | Napoli | |
| Italy | Novartis Investigative Site | Novara | |
| Italy | Novartis Investigative Site | Perugia | PG |
| Italy | Novartis Investigative Site | Rozzano | MI |
| Japan | Novartis Investigative Site | Akashi | Hyogo |
| Japan | Novartis Investigative Site | Fukuoka-city | Fukuoka |
| Japan | Novartis Investigative Site | Koto ku | Tokyo |
| Japan | Novartis Investigative Site | Nagoya | Aichi |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Lebanon | Novartis Investigative Site | Ashrafieh | |
| Malaysia | Novartis Investigative Site | Kuching | Sarawak |
| Malaysia | Novartis Investigative Site | Pulau Pinang | |
| Poland | Novartis Investigative Site | Gdansk | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Saint Petersburg | |
| Russian Federation | Novartis Investigative Site | St Petersburg | |
| Singapore | Novartis Investigative Site | Singapore | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | La Coruna | Galicia |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taoyuan | |
| United States | University of Colorado Cancer Center | Aurora | Colorado |
| United States | Essex Oncology of North Jersey PA | Belleville | New Jersey |
| United States | Highlands Oncology Group . | Fayetteville | Arkansas |
| United States | Loma Linda University . | Loma Linda | California |
| United States | Maryland Oncology Hematology P A Dept of Assoc Onc Hem | Rockville | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Belgium, Brazil, Bulgaria, China, Colombia, Czechia, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, Poland, Russian Federation, Singapore, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | To collect safety data: adverse events and serious adverse events | Until no patients are left on study up to 5 years |