Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jan 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with metastatic pancreatic adenocarcinoma, which is a type of advanced pancreatic cancer that has spread beyond the pancreas. The researchers are testing a combination of three medications: S-1, nab-paclitaxel, and gemcitabine. The goal is to find the right dosage that is safe and effective for patients. This trial is currently recruiting participants aged 18 and older who have not yet received treatment for their cancer and have measurable disease, meaning their condition can be assessed through imaging tests like CT scans or MRIs.

To participate, individuals must have a confirmed diagnosis of pancreatic adenocarcinoma and be in good general health, with a life expectancy of more than six months. Participants can expect to take the medications, undergo regular health assessments, and receive close monitoring throughout the trial. It's important for potential participants to understand that they need to meet specific health criteria and will be required to follow safety guidelines, including using contraception if they are of child-bearing potential. If you or a loved one is interested in this trial, it could be an opportunity to access new treatment options while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed pancreatic adenocarcinoma (poorly differentiated carcinoma is allowed in the absence of neuroendocrine features or squamous differentiation)
• • 2. Treatment-naï ve stage IV disease (measurable disease is required). Prior adjuvant chemotherapy or radiochemotherapy is allowed, if completed ≥ 6 months before enrollment.
• • 3. 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
• • 4. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
• • 5. Life expectancy \> 6 months in the opinion of his/her treating physician.
• • 6. At least 18 years of age
• • 7. 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
• • 8. 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.
• 9. Adequate bone marrow function:
• • Absolute neutrophil count (ANC) ≥ 1500/uL Platelet count ≥ 100,000/uL Hemoglobin ≥ 9.0 g/dL
• 10. 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)
• • 11. 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 )
• • 12. Able to take the oral study medication (S-1)
• • 13. No clinically significant abnormal ECG findings within 28 days (4 weeks) prior to enrollment
• Exclusion Criteria:
• • 1. Have known endocrine pancreatic tumors or ampullary cancer
• • 2. Have received first line treatment for metastatic pancreatic cancer
• • 3. 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)
• • 4. 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.
• • 5. Have known central nervous system (CNS) malignancy or metastasis (screening is not required)
• • 6. Have concurrent hematologic malignancies, acute or chronic leukemia
• • 7. 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)
• • 8. Women with a positive pregnancy test or who are breastfeeding
• • 9. Have participated within the last 30 days in a clinical trial involving an investigational product
• • 10. 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.
• • 11. Current peripheral sensory neuropathy ≥ Grade 2
• • 12. Any social condition or diseases judged ineligible by physician for participation in the study due to safety concern