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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03077659
Other study ID # NANOPAC-2016-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 6, 2017
Est. completion date October 4, 2018

Study information

Verified date July 2019
Source NanOlogy, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15 mg/mL in subjects with prostate cancer scheduled for prostatectomy.


Description:

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Study Design


Intervention

Drug:
NanoPac®
Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Locations

Country Name City State
United States University of Southern California Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
NanOlogy, LLC US Biotest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs. Day 1 to Day 29
Secondary Tumor Response Based on Change in Image Volume on mpMRI Tumor response to treatment with NanoPac was determined by evaluating the change in image volume with multiparametric MRI (mpMRI) within three months prior to consent and again within 48 hours of the prostatectomy procedure (Day 29). In those cases where two dimensions/axes were available, width was imputed to height for the purposes of calculation, i.e. the lesion was assumed to be an oblate spheroid. In those cases where only one dimension/axis was available, that dimension/axis was imputed for all three dimensions i.e. the lesion was assumed to be a sphere. For this reason, analyses were performed for all subjects with two dimensions available, as well as those for which at least one dimension was available. The data presented for this outcome measure is the one dimension lesion volume calculation: Lesion Volume (cc) = (3.14/6)*(length)³, where length is the longer or only measured dimension. Up to three months prior to consent and Day 29
Secondary Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) Prostate tissue samples were obtained via biopsy at baseline and immediately prior to prostatectomy (Day 29). Histologic evaluation of these samples was used to determine the Gleason score, and the results at baseline and Day 29 were used to evaluate the tumor response to treatment with NanoPac®. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis. Screening and Day 29
Secondary Percentage of Sample Considered Adenocarcinoma Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma Day 29 (prostatectomy)
Secondary Concentration of Paclitaxel in the Systemic Circulation Pharmacokinetic samples were taken on Day 1 at 1, 2, 4, and 6 hours post-injection, and weekly until prostatectomy. All numeric paclitaxel concentration data above the Lower Limit of Quantitation (25 pg/mL) was tabulated by cohort. Day 1, Day 8, Day 15, Day 22, and Day 29
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