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

Roche

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Alectinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01871805

NP28761

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

134 participants in 2 patient groups

Alectinib: Phase I (Dose Escalation)

Experimental group

Description:

Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons.

Treatment:

Drug: Alectinib

Alectinib (Phase II: RP2 dose)

Experimental group

Description:

Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.

Treatment:

Drug: Alectinib