Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT03077685.
See trial information on ClinicalTrials.gov for a list of participating sites.
In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced
pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile
Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Subjects will be enrolled in sequential cohorts of NanoPac® at escalating doses, at a
volume based on up to 20% of calculated tumor volume (with a maximum injection volume of
5 mL per subject). During the first phase of the trial (dose escalation), each cohort
will have three subjects, with cohorts enrolled sequentially starting at the lowest
concentration. Following DSMB review of the cohort data, the next cohort may begin
enrolling, an additional three subjects at the current dose may be enrolled, or if the
first dose does not provide adequate safety and tolerability the study may be halted.
The dose determined to be most suitable for further evaluation, defined as the highest
dose with an acceptable safety and tolerability profile as determined by the Data Safety
Monitoring Board (DSMB), will be the dose used in the second phase of the study which
will enroll 22 additional subjects who will receive two injections of NanoPac® at the
same dose one month apart. In the third phase of the study, up to 30 subjects will
receive up to four injections of NanoPac at the same dose, one month apart.
Plasma samples will be taken at various time points on the day of NanoPac® injection as
well as once at each of the study visits, to characterize the pharmacokinetics (PK) of
ITU NanoPac®.
Subjects will be followed for 12 months after NanoPac® injection for safety, overall
survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen
(CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging).
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationNanOlogy, LLC
- Primary IDNANOPAC-2016-05
- Secondary IDsNCI-2017-01955
- ClinicalTrials.gov IDNCT03077685