Status:
NO_LONGER_AVAILABLE
Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK t...
Eligibility Criteria
Inclusion
- Participants with locally advanced (American Joint Committee on Cancer \[AJCC\] Stage IIIB) not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3
- Histologically confirmed NSCLC
- Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test
- After disease progression on or intolerance to prior ALK TKI therapy: 1) participants need to have a minimum washout period of at least 5 half-lives between the last dose of ALK TKI therapy or other targeted therapies and the first dose of study treatment; 2) participants must have recovered from treatment toxicities to less than or equal to (\</=) Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease \[ILD\], they must have fully recovered); 3) participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy for locally advanced or metastatic disease
- Recovery from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
- Adequate hematological and renal function
- Agreement to use highly effective methods of contraception per protocol definitions
Exclusion
- Prior therapy with alectinib
- Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids within 1 week prior to Day 1 to manage CNS symptoms
- Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
- Participants with liver disease
- Any clinically significant concomitant disease or condition that could interfere with the conduct of the study
- Active or uncontrolled infectious diseases requiring treatment
- History of organ transplant
- Participants with baseline QTc \> 470 milliseconds (ms) or participants with symptomatic bradycardia
- Pregnant or lactating, or intending to become pregnant during the study
- History of hypersensitivity to any of the additives in alectinib formulation
- 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 participants before trial entry
- Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02271139
Last Update
March 9 2017
Active Locations (45)
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1
University of Alabama
Bimingham, Alabama, United States, 35226
2
Southern Cancer Center
Daphne, Alabama, United States, 36526
3
Southern Cancer Center
Mobile, Alabama, United States, 36607
4
Southern Cancer Center - Mobile
Mobile, Alabama, United States, 36608