Completed PHASE1 INTERVENTIONAL 2-arm NCT01634763

Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

A Phase I, Multicenter, Open-label Dose Escalation Study of LDK378, Administered Orally in Japanese Patients With Tumors Characterized by Genetic Alterations in ALK

Sponsor: Novartis Pharmaceuticals

Conditions Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Interventions LDK378

Updated 5 times since 2017 Last updated: Dec 16, 2020 Started: Jun 30, 2012 Primary completion: Jan 31, 2016 Completion: Jan 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK) and is currently completed. Novartis Pharmaceuticals leads this study, which shows 5 recorded versions since 2012 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Jun 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Status Flow

Change History

Eligibility Summary

Contact Information

Study Locations

Related Trials