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This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable.
The main questions the study aims to answer are:
Study participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ACT-IOP-003 Once Weekly | Experimental | Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks |
|
| Cohort 2: ACT-IOP-003 Twice Weekly | Experimental | Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) | Combination Product | The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs) | Screening through Week 20 |
| Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Incidence of clinically significant abnormalities in physical examinations | Screening through Week 20 |
| Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Incidence of clinically significant abnormalities in vital signs | Screening through Week 20 |
| Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Incidence of clinically significant abnormalities in clinical laboratory tests (clinical chemistry, hematology, urinalysis) | Screening through Week 20 |
| Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting | Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs) | Screening through Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Plasma PK of gemcitabine pre- and post-dose as measured by Cmax | Screening through Week 8 |
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Marquette | Contact | 619-341-2232 | allison@continuitybiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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5 + 1 (modified 3 +3 design)
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|
Plasma PK of gemcitabine pre- and post-dose as measured by tmax |
| Screening through Week 8 |
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Plasma PK of gemcitabine pre- and post-dose as measured by t1/2 | Screening through Week 8 |
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Plasma PK of gemcitabine pre- and post-dose as measured by Vd | Screening through Week 8 |
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Plasma PK of gemcitabine pre- and post-dose as measured by AUC0-∞ | Screening through Week 8 |
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Plasma PK of gemcitabine pre- and post-dose as measured by AUCτ | Screening through Week 8 |
| Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose | Plasma PK of gemcitabine pre- and post-dose as measured by clearance (CL) | Screening through Week 8 |
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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