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CompletedPhase 1 / Phase 2NCT01871805
Official study title

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Study summary

This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAlectinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 21, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?42 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: Alectinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
ALK→
Treatment approach
Targeted therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC
  • ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
  • NSCLC that has failed crizotinib treatment
  • Measurable disease as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
  • Adequate hematologic, hepatic and renal function
Reasons someone may not be able to joinExclusion criteria
  • Prior therapy with ALK inhibitor other than crizotinib
  • Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
  • History of serious cardiac dysfunction
  • History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
  • Clinically significant gastrointestinal abnormality that would affect absorption of the drug
  • Pregnant or lactating women

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • University of California IrvineIrvine, California
  • UCSD Moores Cancer CenterLa Jolla, California
  • Loma Linda Cancer CenterLoma Linda, California
  • UCLALos Angeles, California
  • Univ of Colorado Canc CtrAurora, Colorado
  • National Jewish HealthDenver, Colorado
  • Lynn Regional Cancer Center WestBoca Raton, Florida
  • Florida Hospital Cancer InstOrlando, Florida
  • UF Health OrlandoOrlando, Florida
  • H. Lee Moffitt Cancer Center and Research Inst.Tampa, Florida
  • University of Illinois Cancer CenterChicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2018. Always confirm current availability with the study team.

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