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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe heart condition classified as Class III or IV according to the New York Heart Association guidelines.You have a known allergy or extreme sensitivity to the study drug.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: NanoPac
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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