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 April 2012 by Novartis

First Received on January 24, 2011. Last Updated on April 17, 2012 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT01283516

Purpose

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

Condition	Intervention	Phase
Tumors Characterized by Genetic Abnormalities of ALK	Drug: LDK378	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Determination of the proper dose of LDK378 to be used in clinical trials [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Type and category of study drug related adverse events [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]
Absorption and plasma concentrations of LDK378 [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
Overall response rate of tumor [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2011
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LDK378 previously treated with ALK NSCLC previously treated with an ALK inhibitor	Drug: LDK378
Experimental: LDK378 not previously treated with ALK NSCLC not previously treated with an ALK inhibitor	Drug: LDK378
Experimental: LDK378 on other ALK + tumors Other tumors that are ALK positive other than NSCLC	Drug: LDK378

Eligibility

Criteria

Inclusion Criteria:

• Tumor must be confirmed to be ALK positive

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283516

Contacts

Contact: Novartis Pharmaceuticals

+1(800)340-6843

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Clinical Disclosure Office, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01283516 History of Changes
Other Study ID Numbers:	CLDK378X2101, 2010-019827-70
Study First Received:	January 24, 2011
Last Updated:	April 17, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada United Kingdom: Research Ethics Committee Spain: Ministerio de Sanidad y Politico Social-Agencia Espanola de Medicamentos y Productos Sanitarios Germany:The Federal Institute for Drugs and Medical Devices (BfArM) Belgium: Belgian Federal Public Service Netherlands: Dutch Healthcare Inspectorate (IGZ) Italy: Ministry of Labor, Health & Social Affairs, Department of Innovation Australia: Therapeutic Goods Administration China: State Food & Drug Administration (SFDA) Thailand: Food & Drug Administration New Zealand: New Zealand Medicines & Medical Devices Safe Authority (MedSafe) Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Novartis:

ALK inhibitor,
NSCLC,
LDK378,
genetic abnormalities

Additional relevant MeSH terms:

Congenital Abnormalities
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012