Locally Advanced Pancreatic Adenocarcinoma Clinical Trial
Official title:
Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Verified date | November 2023 |
Source | NanOlogy, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
Status | Completed |
Enrollment | 54 |
Est. completion date | March 15, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent; - Age =18 years; - Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm as documented via imaging (within 6 weeks of Screening); - Subject not a candidate for surgery; - Completion of at least one standard of care IV chemotherapy course for subjects in the dose escalation phase of the study. IV chemotherapy will be initiated prior to first NanoPac injection for subjects in the second and third phases. Hematologic recovery must be confirmed prior to study entry; - Performance Status (ECOG) 0-1 at study entry; - Life expectancy of at least 3 months; - Adequate marrow, liver, and renal function at study entry: - ANC = 1.5 x 109/L - Hemoglobin = 9.5 grams/dL - Platelets = 75 x 109/L - Total bilirubin = 1.5x institutional ULN - AST/ ALT = 2.5x institutional ULN - Creatinine = 1.5x institutional ULN - Effective contraception if the risk of conception exists. Exclusion Criteria: - Thrombotic or embolic events; - Acute or subacute intestinal occlusion; - History of inflammatory bowel disease; - Known hypersensitivity to study drugs; - Known drug or alcohol abuse; - Pregnant or breastfeeding women; - Previous or concurrent history of non-pancreatic malignancy except for non-melanoma skin cancer. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center | El Paso | Texas |
United States | Parkview Cancer Institute | Fort Wayne | Indiana |
United States | Baylor College of Medicine | Houston | Texas |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
NanOlogy, LLC | US Biotest, Inc. |
United States,
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Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment Emergent Adverse Events (safety and tolerability) | Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. | Up to 6 (six) months after NanoPac® injection | |
Secondary | Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® | Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection | Up to 6 (six) months after NanoPac® injection | |
Secondary | Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® | Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection | Up to 6 (six) months after NanoPac® injection | |
Secondary | Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® | Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection | Up to 6 (six) months after NanoPac® injection | |
Secondary | Tumor Response (RECIST) | Tumor burden at 3 months after NanoPac® injection will be compared with baseline tumor burden. | Baseline and every 3 (three) months after NanoPac® injection, up to 12 months | |
Secondary | Change in pain score | Pain scores will be measured using a visual analog scale | Baseline and 3 (three) months after NanoPac® injection | |
Secondary | Change in tumor markers | Tumor markers measured will include CEA and CA19-9 | Baseline, 3 (three) months, and 6 (six) months after NanoPac® injection |
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