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

NCT01685060 | Completed Phase 2 Results DMC

• 2 other identifiers: CLDK378A22012012-003432-24
• Study Type: interventional
• Target: 140
• Locations: 12 countries
• Sites: 52

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

Keywords

Non-Small Cell Lung Cancer; NSCLC; ALK; LDK378; Ceritinib

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) to LDK378 Per Investigator Assessment

  ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

  6 cycles of 28 days up to 24 weeks

Secondary Outcomes (11)

• ORR Per Blinded Independent Review Committee (BIRC) Assessment

  6 cycles of 28 days up to 24 weeks

• Duration of Response (DOR) by Investigator

  6 cycles of 28 days up to 24 weeks

• Duration of Response (DOR) by BIRC

  6 cycles of 28 days up to 24 weeks

• Disease Control Rate (DCR)

  6 cycles of 28 days up to 24 weeks

• Time to Response (TTR) Per Investigator

  6 cycles of 28 days up to 24 weeks

Study Arms (1)

LDK378

EXPERIMENTAL

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

Drug: LDK378

Interventions

LDK378 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).

Also known as: Ceritinib

LDK378

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (52)

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, 72703, United States

Location

City of Hope National Medical Center Dept of Oncology 2

Duarte, California, 91010-3000, United States

Location

University of California at Los Angeles Reg-5

Los Angeles, California, 90095, United States

Location

University of California at San Diego, Moores Cancer Ctr SC

San Diego, California, 92103, United States

Location

Stanford University Medical Center Stanford Cancer Center(2)

Stanford, California, 94304, United States

Location

University of Colorado Hospital SC

Aurora, Colorado, 80045, United States

Location

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

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medical Center SC

Chicago, Illinois, 60637, United States

Location

University of Kansas Cancer Center DeptofUofKansas CancerCenter-2

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas Dept of CCK

Wichita, Kansas, 67214-3728, United States

Location

Maryland Oncology Hematology, P.A. SC

Rockville, Maryland, 20850, United States

Location

Massachusetts General Hospital Mass General

Boston, Massachusetts, 02114, United States

Location

Levine Cancer Institute SC 1

Charlotte, North Carolina, 28203, United States

Location

Sarah Cannon Research Institute Drug Ship - 4

Nashville, Tennessee, 37203, United States

Location

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

Dallas, Texas, 75390, United States

Location

Seattle Cancer Care Alliance SC-1

Seattle, Washington, 98105, United States

Location

University of Wisconsin Univ Wisc 2

Madison, Wisconsin, 53792, United States

Location

Novartis Investigative Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Novartis Investigative Site

Oshawa, Ontario, L1G 2B9, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Marseille, 13915, France

Location

Novartis Investigative Site

Paris, 75970, France

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Avellino, AV, 83100, Italy

Location

Novartis Investigative Site

Livorno, LI, 57124, Italy

Location

Novartis Investigative Site

Monza, MB, 20900, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Perugia, PG, 06129, Italy

Location

Novartis Investigative Site

Parma, PR, 43100, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 464-8681, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Akashi, Hyōgo, 673-8558, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589-8511, Japan

Location

Novartis Investigative Site

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 104-0045, Japan

Location

Novartis Investigative Site

Koto, Tokyo, 135-8550, Japan

Location

Novartis Investigative Site

Fukuoka, 811-1395, Japan

Location

Novartis Investigative Site

Amsterdam, 1081 HV, Netherlands

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Novartis Investigative Site

Maastricht, 5800, Netherlands

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 03080, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 03722, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28369553 DERIVED

• 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.

  PMID: 27432917 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ceritinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 13, 2012
• Study Start: November 26, 2012
• Primary Completion: March 29, 2016
• Study Completion: March 29, 2016
• Last Updated: June 19, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-05

Locations

NL (3); CA (3); IT (6); JP (9); DE (2); SG (1); US (17); FR (2); HK (1); KR (3); GB (1); ES (4)