Actively Recruiting
Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma
Led by Hallym University Medical Center · Updated on 2022-07-05
42
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced gastric and gastroesophageal junction carcinomas (AGC/GEJCs) with MET amplification or MET exon 14 alterations. This study is devided into Phase 1b and Phase 2 study.
CONDITIONS
Official Title
Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to sign written informed consent before any study procedures
- Age 19 years or older, male or female
- Phase 1b: Histologically confirmed metastatic solid tumor progressed after approved therapies or no standard effective therapy available
- Phase 2b: Histologically confirmed locally advanced or metastatic gastric or gastroesophageal carcinoma progressed after first-line fluoropyrimidine-based chemotherapy
- MET amplification (copy number gain ≥3) or MET exon 14 skipping mutation confirmed by targeted DNA sequencing
- Measurable disease by RECIST 1.1 (Phase 2 only); evaluable lesions allowed in Phase 1b
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as defined by study criteria
You will not qualify if you...
- Active, unstable or symptomatic central nervous system lesions; leptomeningeal metastasis excluded
- Recent treatment with nitrosourea or mitomycin C within 6 weeks
- Cytotoxic chemotherapy within 14 days prior to study treatment
- Prior exposure to c-MET inhibitors
- Recent radiotherapy within 4 weeks for wide field or 2 weeks for limited field; resolved acute radiation symptoms
- History of allogeneic bone marrow or organ transplantation
- History of other primary cancers except gastric cancer
- Clinically significant cardiovascular disease including recent acute coronary syndrome, heart failure, low ejection fraction (<50%), significant arrhythmia, or risk factors for arrhythmia
- Uncontrolled hypertension with systolic >180 mmHg or diastolic >100 mmHg despite treatment
- HIV positive or active hepatitis B or C infection; hepatitis B carriers allowed with prophylactic antiviral treatment
- Gastrointestinal disorders impairing function or absorption; ileostomy not allowed
- Any conditions judged by investigator to contraindicate participation (e.g., severe infections, liver dysfunction, lung disease, renal disease, inability to swallow pills, social or psychological problems)
- Pregnant or lactating women
- Medical, psychiatric, cognitive, or other conditions interfering with consent, protocol compliance, or trial completion
- Hypersensitivity to paclitaxel
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hallym University Medical Center
Gyeonggi-do, South Korea
Actively Recruiting
Research Team
B
Bum Jun Kim, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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