A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)
This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01283516
First received: January 24, 2011
Last updated: May 9, 2013
Last verified: May 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 24, 2011 | ||||||||
| Last Updated Date | May 9, 2013 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Determination of the proper dose of LDK378 to be used in clinical trials [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01283516 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK) | ||||||||
| Official Title ICMJE | A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK) | ||||||||
| Brief Summary | This study will assess the safety and efficacy of LDK378 in patients with genetic abnormalities in anaplastic lymphoma kinase (ALK) |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Tumors Characterized by Genetic Abnormalities of ALK | ||||||||
| Intervention ICMJE | Drug: LDK378 | ||||||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 370 | ||||||||
| Estimated Completion Date | March 2015 | ||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: • Tumor must be confirmed to be ALK positive Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Australia, Belgium, Canada, Germany, Italy, Korea, Republic of, Netherlands, New Zealand, Singapore, Spain, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01283516 | ||||||||
| Other Study ID Numbers ICMJE | CLDK378X2101, 2010-019827-70 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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