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Trial record 57 of 190 for:    Oral Cancer | ( Map: Mexico )

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)

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ClinicalTrials.gov Identifier: NCT02075840
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : March 15, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE February 27, 2014
First Posted Date  ICMJE March 3, 2014
Results First Submitted Date  ICMJE February 6, 2018
Results First Posted Date  ICMJE March 15, 2018
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE August 19, 2014
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • Progression-Free Survival (PFS) by Investigator Assessment [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
  • Percentage of Participants With PFS Event by Investigator Assessment [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
Progression-free survival (PFS) as assessed by investigators according to response evaluation criteria in solid tumors (RECIST) v. 1.1 criteria [ Time Frame: Up to 31 months ]
Change History Complete list of historical versions of study NCT02075840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • PFS Independent Review Committee (IRC)-Assessed [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
  • Percentage of Participants With PFS Event by IRC [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
  • Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria [ Time Frame: Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) ]
    CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
  • Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria [ Time Frame: Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) ]
    CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
  • Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
  • Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators [ Time Frame: First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
  • Overall Survival (OS) [ Time Frame: From randomization until death (up to 43 months) ]
    Overall survival (OS) was defined as the time from randomization to death from any cause.
  • Percentage of Participants With OS Event [ Time Frame: From randomization until death (up to 43 months) ]
    Overall survival (OS) was defined as the time from randomization to death from any cause.
  • Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
  • CNS DOR IRC-assessed According to RECIST v1.1 Criteria [ Time Frame: First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm ]
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Area Under The Concentration-Time Curve (AUC) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) ]
  • Maximum Concentration (Cmax) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  • Time to Reach Cmax (Tmax) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  • AUC of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) ]
  • Cmax of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  • Tmax of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  • Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
  • Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
  • Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
  • Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
  • Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
  • HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
  • HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
  • HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
  • HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • Objective response rate (ORR) as determined by the investigators according to RECIST v. 1.1 criteria [ Time Frame: Up to 31 months ]
  • Time to central nervous system (CNS) progression as determined by IRC using RECIST v. 1.1 criteria [ Time Frame: Up to 31 months ]
  • PFS as assessed by independent review committee (IRC) according to RECIST v. 1.1 criteria\n [ Time Frame: Up to 31 months ]
  • Duration of response defined as time from when response (complete or partial [CR or PR]) was first documented until first documented disease progression or death, whichever occurs first. [ Time Frame: Up to 31 months ]
  • Overall survival, defined as the time from randomization until death from any cause [ Time Frame: Up to 42 months ]
  • Incidence of adverse events [ Time Frame: 42 months ]
  • Area under the concentration-time curve (AUC) of alectinib [ Time Frame: Up to 31 months ]
  • Patient reported time to deterioration (TTD) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30/LC13 [ Time Frame: 31 months ]
  • Patient reported health-related quality of life (HRQoL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30/LC13 [ Time Frame: 31 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Official Title  ICMJE Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Brief Summary This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death. The study is expected to last approximately 42 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Alectinib
    Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    Other Name: RO5424802
  • Drug: Crizotinib
    Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Study Arms  ICMJE
  • Experimental: Alectinib
    Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    Intervention: Drug: Alectinib
  • Active Comparator: Crizotinib
    Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    Intervention: Drug: Crizotinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 9, 2016)
303
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2014)
286
Estimated Study Completion Date  ICMJE September 29, 2022
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
  • Life expectancy of at least 12 weeks
  • Eastern cooperative oncology group performance status (ECOG PS) of 0-2
  • Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
  • Adequate renal, and hematologic function
  • Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
  • Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment
  • Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline)
  • Negative pregnancy test for all females of child bearing potential
  • Use of highly effective contraception as defined by the study protocol

Exclusion Criteria:

  • Participants with a previous malignancy within the past 3 years
  • Any gastrointestinal (GI) disorder or liver disease
  • National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
  • History of organ transplant
  • Co-administration of anti-cancer therapies other than those administered in this study
  • Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia
  • Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
  • Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
  • History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
  • Pregnancy or lactation
  • Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Australia,   Bosnia and Herzegovina,   Brazil,   Canada,   Chile,   China,   Costa Rica,   Egypt,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Portugal,   Russian Federation,   Serbia,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Denmark,   Dominican Republic,   Peru,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02075840
Other Study ID Numbers  ICMJE BO28984
2013-004133-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP