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Trial record 2 of 4 for:    nanopac

Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03077685
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Brief Summary:
Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Adenocarcinoma Drug: NanoPac® Phase 2

Detailed Description:

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). 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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 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 Name: 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 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 Name: 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 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 Name: Paclitaxel




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, 6, 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, 6, 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, 6, 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 CT scan (within 6 weeks of Screening);
  • Subject not a candidate for surgery;
  • Completion of at least one standard of care IV chemotherapy course; 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:

    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077685


Contacts
Contact: Shelagh Verco, PhD 805-595-1300 NANOPAC201605@usbiotest.com
Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com

Locations
United States, California
Keck School of Medicine, University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Ana Ortiz    323-442-8107    ana.ortiz@health.usc.edu   
Principal Investigator: Jacques Van Dam, MD, PhD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Liliana Claudia Bancila    310-423-3872    Liliana.bancila@cshs.org   
Principal Investigator: Simon Lo, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Nichole Stewart    713-798-0960    nlstewar@bcm.edu   
Principal Investigator: Mohamed O Othman, MD         
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
Study Director: Shelagh Verco, PhD Director of Clinical Trials, US Biotest, Inc
Principal Investigator: Jacques Van Dam, MD, PhD Keck School of Medicine, University of Southern California

Publications:
Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03077685     History of Changes
Other Study ID Numbers: NANOPAC-2016-05
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NanOlogy, LLC:
pancreatic neoplasms
digestive system neoplasms
pancreatic diseases
digestive system diseases
pancreatic adenocarcinoma
pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action