LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

NCT ID: NCT01685060

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-26
• Study Completion Date: 2016-03-29

Brief Summary

A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LDK378

Patients treated with ceritinib/LDK378 750 mg once-daily, fasted

Group Type: EXPERIMENTAL

LDK378

Intervention Type: DRUG

Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules).

Interventions

LDK378

Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules).

Intervention Type: DRUG

Other Intervention Names

Ceritinib

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
• Age 18 years or older at the time of informed consent.
• Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
• 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
• Patients must have a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
• 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.

Exclusion Criteria

• Patients with known hypersensitivity to any of the excipients of LDK378.
• 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.
• History of carcinomatous meningitis.
• Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
• Clinically significant, uncontrolled heart disease
• Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, United States

City of Hope National Medical Center Dept of Oncology 2

Duarte, California, United States

University of California at Los Angeles Reg-5

Los Angeles, California, United States

University of California at San Diego, Moores Cancer Ctr SC

San Diego, California, United States

Stanford University Medical Center Stanford Cancer Center(2)

Stanford, California, United States

University of Colorado Hospital SC

Aurora, Colorado, United States

Emory University School of Medicine/Winship Cancer Institute Dept of Oncology

Atlanta, Georgia, United States

University of Chicago Medical Center SC

Chicago, Illinois, United States

University of Kansas Cancer Center DeptofUofKansas CancerCenter-2

Kansas City, Kansas, United States

Cancer Center of Kansas Dept of CCK

Wichita, Kansas, United States

Maryland Oncology Hematology, P.A. SC

Rockville, Maryland, United States

Massachusetts General Hospital Mass General

Boston, Massachusetts, United States

Levine Cancer Institute SC 1

Charlotte, North Carolina, United States

Sarah Cannon Research Institute Drug Ship - 4

Nashville, Tennessee, United States

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

Dallas, Texas, United States

Seattle Cancer Care Alliance SC-1

Seattle, Washington, United States

University of Wisconsin Univ Wisc 2

Madison, Wisconsin, United States

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Oshawa, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Marseille, , France

Novartis Investigative Site

Paris, , France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Heidelberg, , Germany

Novartis Investigative Site

Hong Kong, , Hong Kong

Novartis Investigative Site

Avellino, AV, Italy

Novartis Investigative Site

Livorno, LI, Italy

Novartis Investigative Site

Monza, MB, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Perugia, PG, Italy

Novartis Investigative Site

Parma, PR, Italy

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Akashi, Hyōgo, Japan

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Novartis Investigative Site

Sayama, Osaka, Japan

Novartis Investigative Site

Sunto-gun, Shizuoka, Japan

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Novartis Investigative Site

Koto, Tokyo, Japan

Novartis Investigative Site

Fukuoka, , Japan

Novartis Investigative Site

Amsterdam, , Netherlands

Novartis Investigative Site

Groningen, , Netherlands

Novartis Investigative Site

Maastricht, , Netherlands

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seville, Andalusia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

A Coruña, Galicia, Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

London, , United Kingdom

Countries

United States; Canada; France; Germany; Hong Kong; Italy; Japan; Netherlands; Singapore; South Korea; Spain; United Kingdom

References

Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.

Reference Type: DERIVED

PMID: 28369553 (View on PubMed)

Crino L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.

Reference Type: DERIVED

PMID: 27432917 (View on PubMed)

Other Identifiers

2012-003432-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLDK378A2201

Identifier Type: -

Identifier Source: org_study_id