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This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFH375 | Experimental | GFH375, Oral tablets |
|
| Chemotherapy | Active Comparator | There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFH375 | Drug | The experimental group receives GFH375 monotherapy, QD, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | Up to approximately 2 years |
| PFS | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors | Up to approximately 2 years |
| ORR | ORR assessed by investigators and BICR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Li | Contact | +86 21 6882 1388 | jli@genfleet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D005641 | Tegafur |
| C104201 | gimeracil |
| C489337 | potassium oxonate |
| D000093542 | Gemcitabine |
| D007267 | Injections |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 |
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Experimental group: GFH375; Control group: investigator's choice of Chemotherapy
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| Chemotherapy |
| Drug |
The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator. |
|
|
| Up to approximately 2 years |
| DCR | DCRassessed by investigators and BICR | Up to approximately 2 years |
| DoR | DoR assessed by investigators and BICR | Up to approximately 2 years |
| TTR | TTR assessed by investigators and BICR | Up to approximately 2 years |
| The incidence and severity of AEs and SAEs | The incidence and severity of AEs and SAEs | Up to approximately 2 years |
| EORTC QLQ-C30 Score | Changes in EORTC QLQ-C30 | Up to approximately 2 years |
| EORTC QLQ-PAN26 Score | Changes in EORTC QLQ-PAN26 Scores | Up to approximately 2 years |
| Plasma concentrations of GFH375 | Plasma concentrations of GFH375 | Up to approximately 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D004333 | Drug Administration Routes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |