Tucatinib Continuation Study

NCT07768358 | Not Yet Recruiting Phase 4 FDA Drug

• 3 other identifiers: C42510142025-524353-14-002025
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HER2-positive Breast Cancer; Cervical Cancer; Biliary Tract Neoplasms; Urothelial Cancer; Advanced Non-Small Cell Lung Cancer; Gastric or Gastroesophageal Junction Adenocarcinoma (GEC); Colorectal Cancer

Keywords

tucatinib

Outcome Measures

Primary Outcomes (1)

• To monitor the safety and tolerability of tucatinib

  * Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events

  Up to approximately 5 years

Study Arms (1)

tucatinib

EXPERIMENTAL

150 - 300 mg, by mouth, twice a day

Drug: tucatinib

Interventions

tucatinib DRUG

150 - 300 mg, by mouth, twice a day

Also known as: TUKYSA

tucatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Biliary Tract Neoplasms; Colorectal Neoplasms

Interventions

tucatinib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Digestive System Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): March 13, 2032
• Study Completion (Estimated): March 13, 2032
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share