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Nanoparticle Albumin-Bound (nab) Technology

NanoPac® for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by NanOlogy, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy of at least 3 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 3 (three) months after nanopac® injection, up to 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that involves injecting a medication directly into the tumor.

Eligible Conditions
  • Pancreatic Cancer Locally Advanced

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 3 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 3 (three) months after nanopac® injection, up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 3 (three) months after nanopac® injection, up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events (safety and tolerability)
Secondary outcome measures
Change in pain score
Change in tumor markers
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac®
+3 more

Side effects data

From 2018 Phase 2 trial • 16 Patients • NCT03077659
100%
Fatigue
67%
Abdominal Pain
67%
Procalgia
67%
Nausea
67%
Decreased appetite
67%
Anemia
33%
Constipation
33%
Dry mouth
33%
Arthralgia
33%
Tremor
33%
Ileus
33%
Oedema peripheral
33%
Bone pain
33%
Myalgia
33%
Dizziness
33%
Memory impairment
33%
Anxiety
33%
Insomnia
33%
Dysuria
33%
Micturition urgency
33%
Pollakiuria
33%
Erectile dysfunction
33%
Gastroesophageal reflux disease
33%
Hperglycaemia
33%
Hypokalaemia
33%
Nocturia
33%
Leucocystosis
33%
Vision Blurred
33%
Abdominal distension
33%
Lethargy
100%
80%
60%
40%
20%
0%
Study treatment Arm
NanoPac® 6 mg/mL
NanoPac® 10 mg/mL
NanoPac® 15 mg/mL

Trial Design

5Treatment groups
Experimental Treatment
Group I: Third Phase: NanoPac® at Best DoseExperimental Treatment1 Intervention
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.
Group II: Second Phase: NanoPac® at Best DoseExperimental Treatment1 Intervention
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.
Group III: Dose Escalation: NanoPac® 6 mg/mLExperimental Treatment1 Intervention
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
Group IV: Dose Escalation: NanoPac® 15 mg/mLExperimental Treatment1 Intervention
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
Group V: Dose Escalation: NanoPac® 10 mg/mLExperimental Treatment1 Intervention
Intratumorally injected NanoPac® at a volume of up to 20% tumor volume
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NanoPac®
2017
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

NanOlogy, LLCLead Sponsor
10 Previous Clinical Trials
124 Total Patients Enrolled
US Biotest, Inc.Industry Sponsor
17 Previous Clinical Trials
314 Total Patients Enrolled
Shelagh Verco, PhDStudy DirectorVice President, Clinical Development, US Biotest, Inc
3 Previous Clinical Trials
35 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of health risks does NanoPac® present?

"There is some data supporting NanoPac®'s safety, but none yet affirming its efficacy. Consequently, it received a score of 2."

Answered by AI

What is the standard efficacy of NanoPac® for treating patients?

"NanoPac® is the go-to treatment for neoplasm metastasis, but it has also been proven to be effective against other conditions like kaposi sarcoma, fallopian tubes cancer, and more."

Answered by AI

Are there other examples where NanoPac® has been used in research?

"There are presently 873 clinical trials ongoing that study the effects of NanoPac®. These studies are at various stages, with 234 being in Phase 3. Most of these trials originated in Woolloongabba, Queensland; however, there are 46073 total locations running trials for NanoPac®."

Answered by AI

How many individuals are currently enrolled in this experiment?

"As of now, this study is no longer looking for new participants. The clinical trial was first posted on December 1st, 2017 and was last edited on April 7th, 2022. However, there are other trials you may be eligible for; 791 studies involving pancreatic adenocarcinoma locally advanced and 873 NanoPac® trials are actively recruiting patients right now."

Answered by AI

Are there any open positions for this clinical research project?

"The clinical trial, which was posted on December 1st 2017 and edited most recently on April 7th 2022, is not recruiting patients at this time. However, there are 1664 other studies that are actively looking for participants right now."

Answered by AI

At how many different hospitals is this clinical trial taking place?

"There are 4 enrolling patients for this study including Cedars-Sinai Medical Center in Los Angeles, Texas Tech University Health Sciences Center in El Paso, and Parkview Cancer Institute in Fort Wayne. Other locations include three additional medical centres."

Answered by AI
~7 spots leftby Mar 2025