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Anti-mitotic Agent

NanoPac for Lung 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Awards & highlights

Study Summary

This trial is testing if NanoPac, a kind of chemotherapy, can help treat lung cancer by being injected directly into the tumor.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment emergent adverse events
Secondary outcome measures
Change in tumor dimensions
Concentration of paclitaxel in the systemic circulation post-injection
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NanoPacExperimental Treatment1 Intervention
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

NanOlogy, LLCLead Sponsor
10 Previous Clinical Trials
160 Total Patients Enrolled
US Biotest, Inc.Industry Sponsor
17 Previous Clinical Trials
350 Total Patients Enrolled
Shelagh Verco, PhDStudy DirectorUS Biotest, Inc.
3 Previous Clinical Trials
71 Total Patients Enrolled

Media Library

NanoPac (Anti-mitotic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04314895 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: NanoPac
Non-Small Cell Lung Cancer Clinical Trial 2023: NanoPac Highlights & Side Effects. Trial Name: NCT04314895 — Phase 2
NanoPac (Anti-mitotic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04314895 — Phase 2

Frequently Asked Questions

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

Is the NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension a new medication?

"The first clinical trial for NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension was at City of Hope Comprehensive Cancer Center in 1997. 1140 trials have been completed in the years since. There are 873 live trials as of now, with many of them based out of Fort Wayne, Indiana."

Answered by AI

How many participants will this study have in total?

"In order for this clinical trial to commence, a total of 18 patients that meet the inclusion criteria must be found. The sponsor, NanOlogy, LLC, will be running the trial from multiple sites, two of which are Parkview Research Institute in Fort Wayne, Indiana and Johns Hopkins in Baltimore, Maryland."

Answered by AI

Is this trial available in many different locations throughout Canada?

"There are 4 available for this trial including Parkview Research Institute in Fort Wayne, Johns Hopkins in Baltimore, and University of North carolina Chapel Hill in Chapel Hill. Other locations include 4 other locations."

Answered by AI

Are researchers still enrolling participants for this experiment?

"That is accurate. The clinicaltrials.gov website has current information indicating that this study is open for recruitment. This trial was originally posted on April 14th, 2021 and was last updated on March 15th, 2022. There are 4 sites participating in this study and they are looking for a total of 18 patients."

Answered by AI

Has the NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension gone through the necessary channels for FDA approval?

"Because NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension is only in Phase 2 clinical trials, there is not yet evidence of efficacy. However, there is some data supporting its safety, which earned it a score of 2."

Answered by AI

What indications has NanoPac been shown to be effective for?

"NanoPac (a sterile powder that contains nanoparticulate paclitaxel) is most often used to treat neoplasm metastasis. However, it can also help patients with kaposi sarcoma, fallopian tubes cancer, and other conditions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of NanoPac Intratumoral Injection in Lung Cancer
2021. "Trial of NanoPac Intratumoral Injection in Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04314895.
~4 spots leftby Apr 2025
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