Actively Recruiting
Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Led by Chang Gung Memorial Hospital · Updated on 2024-01-29
70
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine (GAS) in subjects with metastatic pancreatic adenocarcinoma. This study is a dose escalation and dose expansion study with the objective to establish the MTD and/or RP2D and/or DLT of nab-paclitaxel and gemcitabine in combination with a body surface area(BSA)-based dose of S-1 in subject with metastatic pancreatic adenocarcinoma.
CONDITIONS
Official Title
Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic adenocarcinoma without neuroendocrine or squamous differentiation
- Treatment-naïve stage IV metastatic disease with measurable tumor of at least 10 mm by CT or MRI
- ECOG performance status of 0 or 1
- Life expectancy greater than 6 months as determined by physician
- Age 18 years or older
- Ability to understand and consent to the study and follow study procedures
- Fertile patients agree to use effective contraception during study participation
- Adequate bone marrow function: ANC ≥ 1500/uL, platelets ≥ 100,000/uL, hemoglobin ≥ 9.0 g/dL
- Adequate liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN) or ≤ 3.5 mg/dL with biliary drainage; AST and ALT ≤ 3.0 times ULN or ≤ 5.0 times ULN with liver metastases
- Adequate kidney function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
- Able to take oral study medication (S-1)
- No significant abnormal ECG within 28 days before enrollment
You will not qualify if you...
- Known endocrine pancreatic tumors or ampullary cancer
- Previous first-line treatment for metastatic pancreatic cancer
- Serious active infections or major comorbidities such as stroke, uncontrolled arrhythmia, heart failure, or active autoimmune disease
- History of HIV or hepatitis B or C infection (except treated hepatitis B carriers or undetectable hepatitis C RNA)
- Known central nervous system malignancy or metastasis
- Concurrent blood cancers, acute or chronic leukemia
- Active additional malignancies requiring treatment within past 6 months except certain skin cancers or carcinoma in situ
- Positive pregnancy test or breastfeeding
- Participation in another investigational clinical trial within past 30 days
- Unable to swallow capsules or significant gastrointestinal diseases affecting absorption or function
- Peripheral sensory neuropathy grade 2 or higher
- Social or medical conditions deemed unsafe for study participation by physician
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chang-Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
Not Yet Recruiting
2
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan
Actively Recruiting
Research Team
W
Wen-Kuan Huang, MD, PhD
CONTACT
H
Hao-Yun Hsiao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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