NCT03077685

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

5.3 years

First QC Date

February 28, 2017

Results QC Date

March 19, 2024

Last Update Submit

June 19, 2024

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

pancreatic neoplasmsdigestive system neoplasmspancreatic diseasesdigestive system diseasespancreatic adenocarcinomapancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability)

    Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

    Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects.

Secondary Outcomes (5)

  • Target Tumor Assessment

    Week 24

  • Plasma Paclitaxel Concentration (pg/mL)

    Day 1 and Week 24

  • Pain (Visual Analog Scale) Score

    Day 1 (pre-injection) and Week 24

  • Serum CA19-9 Level

    Day 1 (Pre-Injection) and Week 24

  • Serum CEA Levels

    Day 1 (Pre-Injection) and Week 24

Study Arms (5)

Dose Escalation: NanoPac® 6 mg/mL

EXPERIMENTAL

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume

Drug: NanoPac®

Dose Escalation: NanoPac® 10 mg/mL

EXPERIMENTAL

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume

Drug: NanoPac®

Dose Escalation: NanoPac® 15 mg/mL

EXPERIMENTAL

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume

Drug: NanoPac®

Second Phase: NanoPac® at Best Dose

EXPERIMENTAL

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.

Drug: NanoPac®

Third Phase: NanoPac® at Best Dose

EXPERIMENTAL

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the third phase will be determined during the dose escalation phase. Subjects will receive four NanoPac® administrations, with the injections administered one month apart.

Drug: NanoPac®

Interventions

NanoPac®DRUG

Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.

Also known as: Paclitaxel
Dose Escalation: NanoPac® 10 mg/mLDose Escalation: NanoPac® 15 mg/mLDose Escalation: NanoPac® 6 mg/mLSecond Phase: NanoPac® at Best DoseThird Phase: NanoPac® at Best Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • 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.

    PMID: 19097774BACKGROUND

  • Taxol® (paclitaxel) Injection Package Insert. Bristol-Myers Squibb Company. Rev July 2011.

    BACKGROUND

  • ABRAXANE Package Insert. Celgene Company. Rev July 2015.

    BACKGROUND

  • 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.

    PMID: 24131140BACKGROUND

  • Sharma NR, Lo SK, Hendifar A, Othman MO, Patel K, Mendoza-Ladd A, Verco S, Maulhardt HA, Verco J, Wendt A, Marin A, Schmidt CM, diZerega G. Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome. Pancreas. 2023 Mar 1;52(3):e179-e187. doi: 10.1097/MPA.0000000000002236.

    PMID: 37782888DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsDigestive System NeoplasmsPancreatic DiseasesDigestive System Diseases

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Mark Mitchell
Organization
NanOlogy, LLC
Mark.Mitchell@dfb.com
8179004074

Study Officials

  • Shelagh Verco, PhD

    Vice President, Clinical Development, NanOlogy, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Open-label, dose-escalating, Phase IIa trial.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 13, 2017

Study Start

December 1, 2017

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

June 24, 2024

Results First Posted

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)