Clinical trial · Interventional
Tucatinib Continuation Study
TUCATINIB CONTINUATION PROTOCOL: AN OPEN-LABEL STUDY FOR PARTICIPANTS FROM TUCATINIB CLINICAL STUDIES
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric or Gastroesophageal Junction Adenocarcinoma (GEC) | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tucatinib | Drug | Tucatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tucatinib
- description
- 150 - 300 mg, by mouth, twice a day
- interventionNames
- Drug: tucatinib
Primary outcomes (1)
- measure
- To monitor the safety and tolerability of tucatinib
- timeFrame
- Up to approximately 5 years
- description
- * Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available