Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Recruiting now · Phase 1
Conditions studied: Metastatic Pancreatic Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06229496
- Run by
- Chang Gung Memorial Hospital
- People needed
- 70
- Starts
- 2023-08-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed pancreatic adenocarcinoma (poorly differentiated carcinoma is allowed in the absence of neuroendocrine features or squamous differentiation)
- Treatment-naï ve stage IV disease (measurable disease is required). Prior adjuvant chemotherapy or radiochemotherapy is allowed, if completed ≥ 6 months before enrollment.
- Measurable disease defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- Life expectancy > 6 months in the opinion of his/her treating physician.
- At least 18 years of age
- Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and sign the IRB-approved written informed consent
- Fertile female and male patients with child-bearing potential agree to use adequate contraceptive measures prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1500/uL Platelet count ≥ 100,000/uL Hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 X ULN (≤3.5 mg/dL if with adequate biliary tract drainage/stent placement) AST ≤ 3.0 X ULN (≤5.0X ULN if liver metastases are present) ALT ≤ 3.0 X ULN (≤5.0X ULN if liver metastases are present)
- Adequate renal function (defined as serum creatinine ≤ 1.5 X ULN or creatinine clearance rate (CCr) ≥ 50 mL/min (calculated by Cockroft-Gault formula; male: [(140 - age in years) × weight in kg)]/[72 × serum creatinine(mg/dL)];female=male x 0.85 )
- Able to take the oral study medication (S-1)
- No clinically significant abnormal ECG findings within 28 days (4 weeks) prior to enrollment
You may not qualify if…
- Have known endocrine pancreatic tumors or ampullary cancer
- Have received first line treatment for metastatic pancreatic cancer
- Have a serious concomitant active infection or other major comorbidities that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol (e.g., stroke, uncontrolled arrhythmia, heart failure, or active autoimmune disease)
- Have HIV history or hepatitis B and C infection, except for prescribing anti-hepatitis B medications for hepatitis B carrier and undetectable HCV RNA level for hepatitis C prior to enrollment.
- Have known central nervous system (CNS) malignancy or metastasis (screening is not required)
- Have concurrent hematologic malignancies, acute or chronic leukemia
- Have known additional malignancy that is progressing or required active treatments within the past 6 months, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast or cervical cancer)
- Women with a positive pregnancy test or who are breastfeeding
- Have participated within the last 30 days in a clinical trial involving an investigational product
- Unable to swallow capsules or has diseases significantly affecting gastrointestinal function or resection of the stomach or small bowel, malabsorption syndrome, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
- Current peripheral sensory neuropathy ≥ Grade 2
- Any social condition or diseases judged ineligible by physician for participation in the study due to safety concern
Where it is running
- Chiayi Chung Gung Memmorial Hospital — Chiayi City, Taiwan (enrolling)
- Chang-Gung Memorial Hospital, Linkou Branch — Taoyuan, Taiwan (enrolling)
- Chang-Gung Memorial Hospital, Kaohsiung Branch — Kaohsiung City, Taiwan
Full record on ClinicalTrials.gov
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