History of Changes for Study: NCT03077685

Trial of NanoPac in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Latest version (submitted March 19, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	March 7, 2017	None (earliest Version on record)
2	April 12, 2017	Study Status and Contacts/Locations
3	June 12, 2017	Arms and Interventions, Outcome Measures, Study Status, Study Description, Study Identification and Study Design
4	August 11, 2017	Recruitment Status, Study Status, Contacts/Locations and Oversight
5	September 12, 2017	Study Status
6	October 4, 2017	Study Status and Contacts/Locations
7	October 18, 2017	Eligibility and Study Status
8	October 19, 2017	Conditions and Study Status
9	December 13, 2017	Study Status and Contacts/Locations
10	February 20, 2018	Eligibility, Study Status and Outcome Measures
11	May 1, 2018	Study Status, Study Description, Eligibility and Arms and Interventions
12	June 22, 2018	Study Status and Contacts/Locations
13	June 28, 2018	Contacts/Locations and Study Status
14	August 21, 2018	Study Status and Contacts/Locations
15	January 24, 2019	Arms and Interventions, Study Status, Eligibility, Study Design and Study Description
16	August 26, 2019	Contacts/Locations and Study Status
17	June 26, 2020	Study Status and Contacts/Locations
18	October 27, 2020	Outcome Measures, Arms and Interventions, Study Design, Study Status, IPDSharing, Contacts/Locations, Eligibility and Study Description
19	November 29, 2021	Study Status and Contacts/Locations
20	April 7, 2022	Recruitment Status, Study Status and Contacts/Locations
21	November 7, 2023	Recruitment Status, Study Status and Study Design
22	March 19, 2024	Quality Control Review has not concluded Returned: April 16, 2024 Study Status, Outcome Measures, Document Section, Results, Contacts/Locations, Study Design and Study Description

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Study NCT03077685
Submitted Date: March 7, 2017 (v1)

Study Identification


Unique Protocol ID:	NANOPAC-2016-05
Brief Title:	Trial of NanoPac in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Official Title:	Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Secondary IDs:

Study Status


Record Verification:	March 2017
Overall Status:	Not yet recruiting
Study Start:	May 2017
Primary Completion:	June 2018 [Anticipated]
Study Completion:	June 2018 [Anticipated]

First Submitted:	February 28, 2017
First Submitted that Met QC Criteria:	March 7, 2017
First Posted:	March 13, 2017 [Actual]

Last Update Submitted that Met QC Criteria:	March 7, 2017
Last Update Posted:	March 13, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	NanOlogy, LLC
Responsible Party:	Sponsor
Collaborators:	US Biotest, Inc.

Study Description

Brief Summary:

Open-label, dose-escalating, Phase IIa trial of NanoPac to treat subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas via direct intratumoral injection.

Detailed Description:

In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas 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). 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 enroll additional subjects to provide a cohort of up to 12 subjects at that dose level.

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 intratumoral NanoPac.

Subjects will be followed for three 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). A follow-up visit may be conducted at six months, as applicable.

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Sequential Assignment
	Open-label, dose-escalating, Phase IIa trial. Subjects will be enrolled in sequential cohorts of a fixed concentration of NanoPac at a volume correlating up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). 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 enroll additional subjects to provide a cohort of up to 12 subjects at that dose level.
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	30 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: NanoPac 6 mg/mL Intratumorally injected NanoPac at a volume of up to 20% tumor volume	Drug: NanoPac Subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas will receive intratumoral (ITU) NanoPac (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection. Prior to study entry, subjects will have received standard of care (SOC) treatment (including IV chemotherapy) and hematologic recovery will be confirmed before NanoPac is administered. Other Names: Paclitaxel
Experimental: NanoPac 10 mg/mL Intratumorally injected NanoPac at a volume of up to 20% tumor volume	Drug: NanoPac Subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas will receive intratumoral (ITU) NanoPac (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection. Prior to study entry, subjects will have received standard of care (SOC) treatment (including IV chemotherapy) and hematologic recovery will be confirmed before NanoPac is administered. Other Names: Paclitaxel
Experimental: NanoPac 15 mg/mL Intratumorally injected NanoPac at a volume of up to 20% tumor volume	Drug: NanoPac Subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas will receive intratumoral (ITU) NanoPac (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection. Prior to study entry, subjects will have received standard of care (SOC) treatment (including IV chemotherapy) and hematologic recovery will be confirmed before NanoPac is administered. Other Names: Paclitaxel

Outcome Measures


Primary Outcome Measures:
1.	Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to 3 (three) months after NanoPac injection ] Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Secondary Outcome Measures:
1.	Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac [ Time Frame: Up to 3 (three) months after NanoPac injection ] Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 8, and 24 hours post-injection, and again at all study visits post-injection
2.	Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac [ Time Frame: Up to 3 (three) months after NanoPac injection ] Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 8, and 24 hours post-injection, and again at all study visits post-injection
3.	Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac [ Time Frame: Up to 3 (three) months after NanoPac injection ] Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 8, and 24 hours post-injection, and again at all study visits post-injection
4.	Tumor Response (RECIST) [ Time Frame: Baseline and 3 (three) months after NanoPac injection ] Tumor burden at 3 months after NanoPac injection will be compared with baseline tumor burden.
5.	Change in pain score [ Time Frame: Baseline and 3 (three) months after NanoPac injection ] Pain scores will be measured using a visual analog scale
6.	Change in tumor markers [ Time Frame: Baseline and 3 (three) months after NanoPac injection ] Tumor markers measured will include CEA and CA19-9

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Signed informed consent; Age 18 to 75 years; Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; located in the tail or body of the pancreas with a diameter of at least 2 cm but no more than 4cm; Performance Status (ECOG) 0-1 at study entry; Life expectancy of at least 3 months; Adequate marrow, liver, and renal function; Platelet count ≥ 75 x 109/L and ANC ≥ 1.5 x 109/L; Effective contraception if the risk of conception exists. Exclusion Criteria: Prior radiation therapy for pancreatic cancer; 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 metastatic pancreatic disease or non-melanoma skin cancer.

Contacts/Locations


Central Contact Person:	Shelagh Verco, PhD Telephone: 805-595-1300 Email: NANOPAC201605@usbiotest.com
Central Contact Backup:	Gere diZerega, MD Telephone: 805-595-1300 Email: gere.dizerega@usbiotest.com
Study Officials:	Shelagh Verco, PhD Study Director Director of Clinical Trials, US Biotest, Inc
Locations:

References


Citations:	Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. PubMed 19097774
	Taxol® (paclitaxel) Injection Package Insert. Bristol-Myers Squibb Company. Rev July 2011.
	ABRAXANE Package Insert. Celgene Company. Rev July 2015.
	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. PubMed 24131140
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