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Trial record 25 of 37 for:    ALECTINIB

LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02450903
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd will continue until the patient experiences disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precludes further treatment, pregnancy, start of a new anticancer therapy, discontinues treatment at the discretion of the patient or investigator, lost to follow-up, death, or study is terminated by Sponsor.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: LDK378 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib
Actual Study Start Date : August 21, 2015
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ceritinib

Arm Intervention/treatment
Experimental: LDK378
Oral LDK378 750mg once daily
Drug: LDK378
Oral LDK378 750mg once daily
Other Name: Oral LDK378 750mg once daily




Primary Outcome Measures :
  1. Overall response rate (ORR) to LDK378 by investigator assessment [ Time Frame: Until disease progression or unacceptable toxicity occurs, or patient withdrawal up to 24 weeks ]
    ORR, defined as the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator.


Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 6 cycles of 28 days up to 24 weeks ]
    DCR, calculated as the proportion of patients with best overall response of CR, PR, or SD evaluated by investigator per RECIST 1.1

  2. Tumor response (TTR) [ Time Frame: 6 cycles of 28 days up to 24 weeks ]
    TTR, calculated as the time from first dose of LDK378 to first documented response (CR or PR) evaluated by investigator per RECIST 1.1

  3. Duration of response (DOR) [ Time Frame: 6 cycles of 28 days up to 24 weeks ]
    DOR, calculated as the time from the date of the first documented response (CR or PR) to the first documented disease progression evaluated by investigator per RECIST 1.1 or death due to any cause

  4. Progression free survival (PFS) [ Time Frame: 6 cycles of 28 days up to 24 weeks ]
    PFS, calculated as the time from first dose of LDK378 to date of first documented disease progression evaluated by investigator per RECIST 1.1 or date of death due to any cause

  5. Overall survival (OS) [ Time Frame: 6 cycles of 28 days up to 24 weeks ]
    OS, calculated as the time from first dose of LDK378 to death from any cause evaluated

  6. Overall intracranial response rate (OIRR) [ Time Frame: 6 cycles of 28 days up to 24 weeks ]
    OIRR, calculated as the proportion of patients with a best overall confirmed response of CR or PR in the brain assessments for patients having measurable brain metastases at baseline

  7. Safety profile of LDK378 by analyzing adverse events (AEs), electrocardiagrams (ECGs) and laboratory abnormalities [ Time Frame: 6 cycles of 28 days up to 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test.
  • Patients must have NSCLC that has progressed at study enrollment.
  • Patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy prior to study enrollment. No particular sequence of prior alectinib and crizotinib is required for enrollment.
  • Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
  • Age 18 years or older at the time of informed consent.

Exclusion Criteria:

  • Patients with known hypersensitivity to any of the excipients of LDK378.
  • Prior therapy with other ALK inhibitor investigational agents except crizotinib and alectinib.
  • Prior systemic anti-cancer (including investigational) therapy aside from alectinib, crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic NSCLC.
  • 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.
  • Patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  • Ptients with history of carcinomatous meningitis.
  • Patient with a concurrent malignancy or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
  • Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450903


Locations
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Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464 8681
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277 8577
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 811-1395
Novartis Investigative Site
Akashi, Hyogo, Japan, 673-8558
Novartis Investigative Site
Sakyo Ku, Kyoto, Japan, 606 8507
Novartis Investigative Site
Natori, Miyagi, Japan, 981-1293
Novartis Investigative Site
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site
Sayama, Osaka, Japan, 589 8511
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site
Koto ku, Tokyo, Japan, 135 8550
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02450903     History of Changes
Other Study ID Numbers: CLDK378A1201
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ceritinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action