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Trial record 1 of 1 for:    NCT01801111
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A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

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: NCT01801111
Recruitment Status : Completed
First Posted : February 28, 2013
Results First Posted : May 26, 2016
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: Erlotinib Drug: Alectinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment
Actual Study Start Date : June 20, 2013
Actual Primary Completion Date : October 24, 2014
Actual Study Completion Date : October 27, 2017


Arm Intervention/treatment
Experimental: Alectinib
Participants will receive alectinib treatment continuously starting from Day 1 Cycle 1 (in 28-day cycles) until disease progression, death, or withdrawal for any other reasons, whichever occurs first. After PD, participants without EGFR mutation will continue treatment with alectinib alone and participants with EGFR mutation will receive alectinib in combination with erlotinib as per discretion of the treating physician.
Drug: Erlotinib
Erlotinib will be administered at a dose of 100 mg via tablet, orally, once daily in combination with alectinib to participants who progressed on alectinib alone treatment as per treating physician discretion.
Other Name: Tarceva

Drug: Alectinib
Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.
Other Name: RO5452802




Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) of Alectinib [ Time Frame: Cycle 1 (up to 28 days) ]
    RP2D was to be determined based on the safety and tolerability profile of the study treatment.

  2. Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]
    DLTs were to be assessed based on the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.3 (NCI-CTCAE v 4.3). DLTs: drug-related toxicities that meet any one of the following criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia continuing for greater than or equal to (>/=) 7 consecutive days or neutropenic fever; Non-hematological toxicity of Grade 3 or higher; Adverse events that require interruption of treatment for a total of >/=7 days.

  3. Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    Tumor response was assessed by IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to less than (<) 10 millimeters (mm). PR was defined as >/=30 percent (%) decrease in the sum of diameters (SoD) of target lesions (taking as reference the baseline SoD). The 95% confidence interval (CI) was computed using Clopper-Pearson method.

  4. Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    Tumor response was assessed by IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    Tumor response was assessed by IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD).

  2. Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in RE Population [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.

  3. Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD).

  4. Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD).

  5. Duration of Response (DoR) as Assessed by IRC in RE Population [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    DoR was defined as the time from the first observation of an objective tumor response (CR or PR) until first observation of progressive disease (PD) according to RECIST v1.1 or death from any cause. CR: disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR: >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). PD: >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. Participants who did not progress or die after a confirmed objective response were censored at the date of their last tumor assessment.

  6. Percentage of Participants With PD as Assessed by IRC According to RECIST v1.1 or Death From Any Cause in Safety Population [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    According to RECIST v1.1, PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions.

  7. Progression Free Survival (PFS) as Assessed by IRC in Safety Population [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    PFS was defined as the time interval between the date of the first treatment and the date of PD or death from any cause, whichever occurred first. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions. PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. Participants who neither progressed nor died at the time of assessment or who were lost to follow-up were censored at the date of the last tumor assessment. Participants with no post-baseline assessments were censored at the date of first dose.

  8. Percentage of Participants Who Died of Any Cause [ Time Frame: Baseline up to death from any cause (up to approximately 4 years) ]
    Percentage of participants who died of any cause was reported.

  9. Overall Survival (OS) [ Time Frame: Baseline up to death from any cause (up to approximately 4 years) ]
    OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. Participants who did not die were censored at the date last known to be alive.

  10. Percentage of Participants Achieving CR, PR or Stable Disease (SD) According to RECIST v1.1 in RE Population [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    The disease control rate (DCR) was defined as the percentage of participants achieving CR, PR, or SD that lasted for at least 16 weeks. Tumor response was assessed by the investigator and IRC according to RECIST v1.1. CR: disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR: >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). PD: >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SoD while on study. The 95% CI was computed using Clopper-Pearson method.

  11. Percentage of Participants Achieving Central Nervous System (CNS) Objective Response as Assessed by IRC According to RECIST v1.1 [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    CNS response was assessed by IRC according to RECIST v1.1. CNS Objective response was defined as percentage of participants with a CR or PR. CR was defined as disappearance of all CNS lesions. PR was defined as >/=30% decrease in the SoD of measurable CNS lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.

  12. Percentage of Participants Achieving CNS Objective Response as Assessed by IRC According to Radiology Assessment in Neuro-Oncology (RANO) Criteria [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up until cutoff 18 August 2014 (up to approximately 53 weeks) ]
    CNS response was assessed by IRC according to RANO criteria. CNS Objective response: percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as complete disappearance of all enhancing measurable, non-measurable disease; stable or improved non-enhancing lesions; no new lesions; no corticosteroids (or only physiologic replacement dose), and clinically stable or improved. PR was defined as >/=50% decrease compared to screening in the sum of the products of the diameters (SPD) of enhancing measurable lesions; no progression of non-measurable disease (enhancing and non-enhancing lesions); no new lesions; no corticosteroids (or only physiologic replacement dose), and clinically stable or improved. The 95% CI was computed using Clopper-Pearson method.

  13. CNS Duration of Response (CDoR) as Assessed by IRC According to RECIST v1.1 [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years) ]
    CDoR was defined as the time from the first observation of a CNS objective response (CR or PR) until first observation of CNS progression as assessed by IRC according to RECIST v 1.1 or death from any cause. CR: disappearance of all CNS lesions. PR: >/=30% decrease in the SoD of measurable CNS lesions (taking as reference the baseline SoD). CNS progression: >/=20% increase in the SoD of measurable CNS lesions (with an absolute increase of at least 5 mm), taking as reference the baseline SoD; 1 or more new CNS lesion(s); and/or unequivocal progression of non-measurable CNS lesions. CDoR was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

  14. CDoR as Assessed by IRC According to RANO Criteria [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up until cutoff 18 August 2014 (up to approximately 53 weeks) ]
    CDoR: time from the CNS objective response until CNS progression as assessed by IRC according to RANO criteria or death from any cause. CR: complete disappearance of all enhancing measurable, non-measurable disease; stable/improved non-enhancing lesions; no new lesions; no corticosteroids, and clinically stable/improved. PR: >/=50% decrease compared to screening in SPD of enhancing measurable lesions; no progression of non-measurable disease; no new lesions; no corticosteroids, and clinically stable/improved. Progression: >/=25% increase in SPD of enhancing measurable lesions compared to best response on study; stable/increasing doses of corticosteroids; significant increase in non-enhancing lesions not caused by co-morbid events; any new lesions; progression of non-measurable disease; or clinical deterioration not attributable to other non-tumor causes. CDoR was estimated by Kaplan-Meier method and 95% CI was assessed using method of Brookmeyer and Crowley.

  15. Percentage of Participants With CNS Progression as Assessed by IRC According to RECIST v 1.1 [ Time Frame: Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up until cutoff 18 August 2014 (up to approximately 53 weeks) ]
    According to RECIST v 1.1, CNS progression was defined as >/=20% increase in the SoD of measurable CNS lesions (with an absolute increase of at least 5 mm), taking as reference the baseline SoD; 1 or more new CNS lesion(s); and/or unequivocal progression of non-measurable CNS lesions.

  16. Maximum Observed Plasma Concentration (Cmax) of Alectinib [ Time Frame: Pre-dose (0 hours [hrs]), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Cmax for alectinib was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 (Pharsight Corporation) software.

  17. Time to Cmax (Tmax) of Alectinib [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Tmax for alectinib was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.

  18. Time to Last Measurable Plasma Concentration (Tlast) of Alectinib [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Tlast for alectinib was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.

  19. Area Under the Plasma Concentration-Time Curve From Time 0 to 10 Hours Post-dose (AUC[0-10]) of Alectinib [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    The AUC(0-10) of alectinib was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).

  20. Area Under the Plasma Concentration-Time Curve From Time 0 to Tlast (AUC[0-last]) of Alectinib [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    The AUC(0-last) of alectinib was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).

  21. Cmax of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Cmax for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.

  22. Tmax of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Tmax for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.

  23. Tlast of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Tlast for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.

  24. AUC(0-10) of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    The AUC(0-10) of alectinib metabolite was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).

  25. AUC(0-last) of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    The AUC(0-last) of alectinib metabolite was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).

  26. Metabolite to Parent Ratio Based on AUC(0-10) [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Metabolite to parent ratio based on AUC(0-10) was computed as AUC(0-10) of metabolite divided by AUC(0-10) of parent drug (alectinib) corrected for the molecular weight of parent divided by the molecular weight of the metabolite.

  27. Metabolite to Parent Ratio Based on AUC(0-last) [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1 ]
    Metabolite to parent ratio based on AUC(0-last) was computed as AUC(0-last) of metabolite divided by AUC(0-last) of parent drug (alectinib) corrected for the molecular weight of parent divided by the molecular weight of the metabolite.

  28. Trough Plasma Concentration (Ctrough) of Alectinib [ Time Frame: Pre-dose (0 hrs) on Day 21 of Cycle 1 ]
  29. Ctrough of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs) on Day 21 of Cycle 1 ]
  30. Peak to Trough Ratio of Alectinib [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Day 21 of Cycle 1 ]
  31. Accumulation Ratio of Alectinib [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Day 1 and Day 21 of Cycle 1 ]
    Accumulation ratio after repeat dosing was computed as AUC(0-10) on Day 21 divided by AUC(0-10) on Day 1.

  32. Accumulation Ratio of Alectinib Metabolite [ Time Frame: Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Day 1 and Day 21 of Cycle 1 ]
    Accumulation ratio after repeat dosing was computed as AUC(0-10) on Day 21 divided by AUC(0-10) on Day 1.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by American Joint Committee on Cancer [AJCC])
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test
  • Prior treatment with crizotinib and progression according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria. Participants had to have a minimum 1-week wash-out period between the last dose of crizotinib and the first dose of study treatment. Participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy
  • Adequate hematologic, hepatic, and renal function
  • Participants with brain or leptomeningeal metastases are allowed if protocol defined criteria are met
  • Measurable disease according to RECIST v1.1 prior to administration of first dose of study drug

Exclusion Criteria:

  • Receipt of any other ALK inhibitors in addition to crizotinib
  • Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks prior to the first dose of study drug
  • Participants who received crizotinib or any other tyrosine kinase inhibitors need to have a minimum 1-week washout period before the first dose of study drug
  • Active or uncontrolled infectious diseases requiring treatment
  • National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
  • History of organ transplant
  • Co-administration of anti-cancer therapies other than those administered in this study
  • Baseline corrected Q-T interval (QTc) greater than (>) 470 milliseconds, or baseline symptomatic bradycardia (less than 45 heart beats per minute)
  • Pregnant or breastfeeding women
  • Known Human Immunodeficiency Virus (HIV) positivity or Acquired Immunodeficiency Syndrome (AIDS)-related illness
  • History of hypersensitivity to any of the additives in the alectinib formulation
  • Any clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in the study

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): NCT01801111


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
UC Irvine Medical Center
Orange, California, United States, 92868
Sharp Memorial Hospital
San Diego, California, United States, 92123
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
UCLA Cancer Center; Premiere Oncology, A Medical Corporation
Santa Monica, California, United States, 90404
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Hospital Cancer Inst
Orlando, Florida, United States, 32804
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Midwestern Regional Medical Center; Office of Research
Zion, Illinois, United States, 60099
United States, Missouri
Washington University; Wash Uni. Sch. Of Med
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89014
United States, New York
Columbia University Medical Center; Department of Hematology/Oncology
New York, New York, United States, 10032
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Australia, New South Wales
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Townsville General Hospital
Douglas, Queensland, Australia, 4184
Belgium
UZ Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
AZ Delta (Campus Wilgenstraat)
Roeselare, Belgium, 8800
Denmark
University Hospital Herlev
Herlev, Denmark, 2730
France
CHU Angers - Hôpital Hôtel Dieu
Angers, France, 49933
Hopital Morvan
Brest, France, 29200
Centre Francois Baclesse
Caen, France, 14076
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon, France, 21000
CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique
Grenoble, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69008
Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology
Marseille cedex 20, France, 13915
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, France, 33600
Hopital Pontchaillou - CHU de Rennes
Rennes, France, 35033
ICO Rene Gauducheau; CEC
St Herblain, France, 44805
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, France, 67091
CHU de Toulouse - Hôpital Larrey
Toulouse, France, 31059
Germany
Charité Campus Virchow-Klinikum; Department of Cardiology
Berlin, Germany, 13353
Diakonie Kaiserswerth; Florence-Nightingale-Krankenhaus
Düsseldorf, Germany, 40489
LungenClinic Großhansdorf
Großhansdorf, Germany, 22927
Lungenklinik Hemer
Hemer, Germany, 58675
Klinikum Koeln-Merheim
Koeln, Germany, 51109
Mathias-Spital Rheine
Rheine, Germany, 48431
Italy
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy, 43100
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli-Venezia Giulia, Italy, 33081
Istituto Nazionale Tumori Regina Elena IRCCS
Roma, Lazio, Italy, 00144
AO San Camillo Forlanini
Roma, Lazio, Italy, 00149
Ospedale San Raffaele
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milano, Lombardia, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana, Italy, 50141
Ospedale Versilia
Lido Di Camaiore, Toscana, Italy, 55043
Presidio Ospedaliero Campo di Marte
Lucca, Toscana, Italy, 55100
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy, 06100
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System; Pharmacy
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 6351
Luxembourg
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210
Netherlands
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie
Maastricht, Netherlands, 6229HX
Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement
Moskva, Moskovskaja Oblast, Russian Federation, 115478
Singapore
National University Hospital; Investigational Medicine Unit
Singapore, Singapore, 119074
Johns Hopkins Singapore
Singapore, Singapore, 308433
Spain
Hospital General Univ. de Alicante
Alicante, Spain, 03010
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Quiron Dexeus
Barcelona, Spain, 08028
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario La Paz
Madrid, Spain, 280146
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Regional Universitario de Malaga
Malaga, Spain, 29010
Hosp Clinico Univ Lozano Blesa
Zaragoza, Spain, 50009
Sweden
Karolinska
Stockholm, Sweden, 17176
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
National Cheng Kung Univ Hosp
Tainan, Taiwan, 00704
National Taiwan University Hospital
Taipei, Taiwan, 10002
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Royal Marsden Hospital;Dept of Haematology Oncology Research
London, United Kingdom, SW3 6HP
Royal Marsden Hospital - London
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01801111     History of Changes
Other Study ID Numbers: NP28673
2012-004455-36 ( EudraCT Number )
First Posted: February 28, 2013    Key Record Dates
Results First Posted: May 26, 2016
Last Update Posted: November 2, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action