Trials / Active Not Recruiting
Active Not RecruitingNCT05382364
Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of Tucatinib (MK-7119) in China Participants With HER2+ Advanced Breast Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to characterize the safety and tolerability of tucatinib (MK-7119) in Chinese participants with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma (GEC), and colorectal cancer.
Conditions
- Metastatic HER2+ Advanced Breast Cancer
- Breast Neoplasms
- Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
- Colorectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tucatinib | Tucatinib 150 mg and 50 mg tablets taken by mouth at a dose of 300 mg twice daily. |
Timeline
- Start date
- 2022-06-29
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2022-05-19
- Last updated
- 2026-03-12
Locations
5 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05382364. Inclusion in this directory is not an endorsement.