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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 : August 28, 2019
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • 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
  • 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
  • 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
  • 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.
  • Change in pain score [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ]
    Pain scores will be measured using a visual analog scale
  • Change in tumor markers [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ]
    Tumor markers measured will include CEA and CA19-9
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • 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
  • 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
  • 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
  • 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.
  • Change in pain score [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ]
    Pain scores will be measured using a visual analog scale
  • Change in tumor markers [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ]
    Tumor markers measured will include CEA and CA19-9
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Official Title  ICMJE Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Brief Summary Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
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 be the dose used in the second phase of the study which will enroll 12 additional subjects who will receive two 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 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 is planned at six months after the first NanoPac® administration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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 be the dose used in the second phase of the study which will enroll 12 additional subjects who will receive two injections of NanoPac® at the same dose one month apart.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Pancreatic Adenocarcinoma
Intervention  ICMJE Drug: NanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Other Name: Paclitaxel
Study Arms  ICMJE
  • Experimental: Dose Escalation: NanoPac® 6 mg/mL
    Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
    Intervention: Drug: NanoPac®
  • Experimental: Dose Escalation: NanoPac® 10 mg/mL
    Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
    Intervention: Drug: NanoPac®
  • Experimental: Dose Escalation: NanoPac® 15 mg/mL
    Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
    Intervention: Drug: NanoPac®
  • Experimental: Second Phase: NanoPac® at Best Dose
    Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® administrations, with the second injection administered one month after the first injection.
    Intervention: Drug: NanoPac®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 phase. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shelagh Verco, PhD 805-595-1300 NANOPAC201605@usbiotest.com
Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077685
Other Study ID Numbers  ICMJE NANOPAC-2016-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NanOlogy, LLC
Study Sponsor  ICMJE NanOlogy, LLC
Collaborators  ICMJE US Biotest, Inc.
Investigators  ICMJE
Study Director: Shelagh Verco, PhD Director of Clinical Trials, US Biotest, Inc
PRS Account NanOlogy, LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP