NCT03194893

A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Alectinib	Alectinib capsules 600 mg twice a day (BID) orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
DRUG	Crizotinib	Crizotinib capsules 250 mg BID orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.

Timeline

• Start date: 2017-07-05
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2017-06-21
• Last updated: 2026-02-20

Locations

29 sites across 9 countries: United States, France, Hong Kong, Italy, Poland, Russia, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study