NCT07768358Not yet recruitingPhase 4
Tucatinib Continuation Study
TUCATINIB CONTINUATION PROTOCOL: AN OPEN-LABEL STUDY FOR PARTICIPANTS FROM TUCATINIB CLINICAL STUDIES
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- First submitted
- 12 Aug 2026
- Start date
- 6 Nov 2026
- Primary completion date
- 13 Mar 2032
- Lead sponsor
- Pfizer
- NCT number
- NCT07768358
- EU CT number
- 2025-524353-14-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 175
- From 6 Nov 2026 to the primary completion date, 13 Mar 2032
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).
- Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.
Other
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Who the study is looking for
- 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.
- Agree to follow the reproductive criteria.
- Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.
- Be capable of giving signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.