A clinical study of oral LDK378 in adult patients with ALK-activated non-small cell lung cancer and who have not been previously treated with crizotinib

Phase 1

• Conditions: on-small cell lung cancer; MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003474-36-ES
• Lead Sponsor: ovartis Farmaceútica, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC that carries an ALK rearrangement defined as 15% or more positive tumor cells as assessed by the FDA-approved FISH test (Abbott Molecular Inc)
2. Age 18 years or older at the time of informed consent.
3. Patients must have NSCLC that has progressed during therapy.
4. Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
5. Patients must have archival tissue, collected either at the time of diagnosis of NSCLC or any time since.
6. Patients must have recovered from all toxicities related to prior anticancer therapies to grade ? 2 except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study

Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
2. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
3. History of carcinomatous meningitis.
4. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
5. Clinically significant, uncontrolled heart disease

Other protocol defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified