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2023-08-01
2026-07-31
2026-07-31
70
NCT06229496
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
INTERVENTIONAL
Dose Escalation and Dose Expansion Study of 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.
Pancreatic ductal adenocarcinoma (PDAC) is the seventh leading cause of cancer- related death worldwide as the second leading cause of cancer mortality in the United States by 2030 . The overall 5-year survival rate is around 5% for advanced PDAC and 15-30% for resected PDAC. While recent advances have emerged in precision medicine and immunotherapy in a variety of cancer types, unfortunately these drugs are not applicable to most patients with PDAC. To date, polychemotherapy combinations remain the mainstay of systemic treatments for advanced PDAC. Of note, FOLFIRINOX is a triplet combination regimen while nab-Paclitaxel and gemcitabine is a doublet combination. Both NALIRIFOX and FOLFIRINOX showed the same median OS with about 11.1 months from NAPOLI 3 and PRODIGE4 trials, respectively, demonstrating the biologically comparable anti-tumor effects. On the other hand, the median OS of 8.5 months of gemcitabine plus nab-paclitaxel raised the question-would it be possible to add the third active drug in this doublet combination to achieve more potential efficacy, being comparable with triplet combination such as FOLFIRINOX or NALIRIFOX. Therefore, in this study the investigator aimed to investigate whether adding S-1 to nab-paclitaxel and gemcitabine as GAS regimen can be a potential triplet combination.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-01-09 | N/A | 2024-01-19 |
2024-01-19 | N/A | 2024-01-29 |
2024-01-29 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: GAS regimen-dose level 1 | COMBINATION_PRODUCT: Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA)
|
| EXPERIMENTAL: GAS regimen-dose level 2 | COMBINATION_PRODUCT: Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)
|
| EXPERIMENTAL: GAS regimen-dose level 3 | COMBINATION_PRODUCT: Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 | |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Overall Survival (OS) | From the start date of study treatment to the date of death. | Through study completion, an average of 3 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Wen-Kuan Huang, MD, PhD Phone Number: 03-3281200 Email: medfox0924@cgmh.org.tw |
Study Contact Backup Name: Hao-Yun Hsiao, MD Phone Number: 03-3281200 Email: hyhsiao@cgmh.org.tw |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
