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Tucatinib Continuation Study

Not Yet RecruitingPhase 4

Sponsor: Pfizer

Conditions: HER2-positive Breast Cancer, Cervical Cancer, Biliary Tract Neoplasms, Urothelial Cancer, Advanced Non-Small Cell Lung Cancer

Interventions: tucatinib

The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment. These participants were part of Pfizer-sponsored tucatinib parent studies that will be closed. Additional follow-up safety information will be collected. This will allow further understanding of the safety profile of tucatinib in participants who continue to receive the study treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Be receiving tucatinib as a study intervention and deriving clinical benefit without evidence of disease progression (as determined by the investigator) in a tucatinib Parent Study.
2. Agree to follow the reproductive criteria.
3. Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.
4. Be capable of giving signed informed consent.

Exclusion Criteria:

1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
2. Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).
3. Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.