Trial record 2 of 2 for:    "LDK378" and "Phase III"

LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01828112
First received: April 2, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The primary purpose of the study is to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: LDK378
Drug: pemetrexed
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    PFS which is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    OS defined as time from date of randomization to date of death due to any cause

  • Overall Response Rate (ORR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)

  • Duration of Response (DOR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer

  • Disease Control Rate (DCR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)

  • Time to response (TTR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    TTR is defined as the time from date of randomization to date of first documented response (CR or PR)


Estimated Enrollment: 236
Study Start Date: June 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDK378 Drug: LDK378
Oral LDK378 750 mg once daily
Active Comparator: pemetrexed or docetaxel Drug: pemetrexed
pemetrexed is 500 mg/m2 IV every 21 days
Drug: docetaxel
docetaxel is 75 mg/m2 every 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
  2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
  3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation

Exclusion Criteria:

  1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828112

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 175 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01828112     History of Changes
Other Study ID Numbers: CLDK378A2303, 2012-005637-36
Study First Received: April 2, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Canadian Health Authorities
France: Haute Autorité de Santé Transparency Commission
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health (DoH), pharmaceutical services
Ireland:
Isreal: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Netherlands: Medicines Evaluation Board (MEB)
Russia:Ministry of Public Health of Russian Federation
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Portugal: Ethics Committee for Clinical Research
Luxembourg: Ministère de la Santé

Keywords provided by Novartis:
Non-Small Cell Lung Cancer, ALK, LDK378

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Crizotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014