This trial has been completed.

Condition tumors characterized by genetic abnormalities of alk
Treatment ldk378
Phase phase 1
Target ALK
Sponsor Novartis Pharmaceuticals
Start date January 2011
End date August 2013
Trial size 303 participants
Trial identifier NCT01283516, 2010-019827-70, CLDK378X2101


This study will assess the safety and efficacy of LDK378 in patients with genetic abnormalities in anaplastic lymphoma kinase (ALK)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
NSCLC previously treated with an ALK inhibitor
NSCLC not previously treated with an ALK inhibitor
Other tumors that are ALK positive other than NSCLC

Primary Outcomes

Determination of the proper dose of LDK378 to be used in clinical trials
time frame: 48 weeks

Secondary Outcomes

Type and category of study drug related adverse events
time frame: 120 weeks
Absorption and plasma concentrations of LDK378
time frame: 120 weeks
Overall response rate of tumor
time frame: 120 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: • Tumor must be confirmed to be ALK positive by FISH Exclusion Criteria: - Pregnant - Active pancreatitis - Active or chronic liver disease Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in September 2016.