Metastatic Pancreatic Adenocarcinoma Clinical Trial
— GASOfficial title:
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
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | July 31, 2026 |
Est. primary completion date | July 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang-Gung Memorial Hospital, Kaohsiung Branch | Kaohsiung | |
Taiwan | Chang-Gung Memorial Hospital, Linkou Branch | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) | To determine a recommended Phase 2 dose (RP2D) of nab-paclitaxel and gemcitabine in combination with body surface area (BSA) - based dose of S-1 in subject with metastatic pancreatic adenocarcinoma | From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years | |
Primary | Dose-limiting toxicity (DLT) | From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years | ||
Primary | Objective response rate (ORR) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. | From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years | |
Secondary | Safety profile of GAS regimen | Safety profile will be recorded and graded according to NCI-CTCAE v 5.0. | From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years | |
Secondary | Disease Control Rate (DCR) | Defined as having complete response, partial response or stable disease at 12 weeks. (based on RECIST Version 1.1) | Through study completion, an average of 3 year | |
Secondary | Duration of Response (DoR) | Time from documentation of tumor response to disease progression. (based on RECIST Version 1.1) | Through study completion, an average of 3 year | |
Secondary | Progression-free Survival (PFS) | From the start date of study treatment to the date of progression disease or death. (based on RECIST Version 1.1) | Through study completion, an average of 3 year | |
Secondary | Overall Survival (OS) | From the start date of study treatment to the date of death. | Through study completion, an average of 3 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
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