Advanced Non-Small Cell Lung Cancer, Biliary Tract Neoplasms, Cervical Cancer, Colorectal Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma (GEC), HER2-positive Breast Cancer, Urothelial Cancer
Conditions
Keywords
tucatinib
Brief summary
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.
Detailed description
The study is seeking participants who * continue to benefit without disease progression from tucatinib as judged by the treating physician. * are willing to follow protocol requirements. All participants in this study will receive tucatinib. Tucatinib will be taken by mouth 2 times a day. We will examine the experiences of people receiving the study medicine. This will help us assess if tucatinib is safe. Participants will stay in the study for up to 5 years or until tucatinib is permanently discontinued, whichever comes first. During this time, they will have one clinical visit every three weeks to receive the study treatment. They will also talk with the treating physician about their experiences.
Interventions
DRUGtucatinib
150 - 300 mg, by mouth, twice a day
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To monitor the safety and tolerability of tucatinib | Up to approximately 5 years | * Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events |
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed