Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

NCT03077659 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NANOPAC-2016-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Prostate

Keywords

prostate cancer; prostatic neoplasms; genital neoplasms, male; urogenital neoplasms; prostatic diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Tumor Response Based on Change in Image Volume on mpMRI

  Up to three months prior to consent and Day 29

• Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)

  Screening and Day 29

• Percentage of Sample Considered Adenocarcinoma

  Day 29 (prostatectomy)

• Concentration of Paclitaxel in the Systemic Circulation

  Day 1, Day 8, Day 15, Day 22, and Day 29

Study Arms (3)

NanoPac® 6 mg/mL

EXPERIMENTAL

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

Drug: NanoPac®

NanoPac® 10 mg/mL

EXPERIMENTAL

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

Drug: NanoPac®

NanoPac® 15 mg/mL

EXPERIMENTAL

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume

Drug: NanoPac®

Interventions

NanoPac® DRUG

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.

Also known as: Paclitaxel

NanoPac® 10 mg/mL; NanoPac® 15 mg/mL; NanoPac® 6 mg/mL

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male; 18 years of age and older
• Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
• ECOG of 0 or 1
• Laboratory requirements:
• WBC \>2500/mm3
• Neutrophil \>1500/mm3
• Hemoglobin \>10 mg/dL
• Platelet \>100,000/ mm3
• AST and ALT \<2.5 x ULN
• Total bilirubin \<1.5 x ULN
• Creatinine \<2 mg/dL
• Normal PT/INR and PTT;
• Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
• Willing to receive an mpMRI

You may not qualify if:

• Evidence of locally advanced or metastatic disease;
• Prostate size ≥ 50 cc
• Prior prostatectomy
• Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) prior to surgery
• Treatment with a prior investigational agent within 30 days of first dose of investigational medication
• Any previous local treatment of the prostate (i.e. radiation)
• Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
• Known sensitivity to any of the study medication components
• History of prior malignancy that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma.

Sponsors & Collaborators

• NanOlogy, LLC: lead
• US Biotest, Inc.: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Prostatic Diseases

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Gere S. diZerega, MD
• Organization: NanOlogy, LLC

gere.dizerega@usbiotest.com

805-595-1300

Study Officials

• Shelagh Verco, PhD

  US Biotest, Inc.

  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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, dose rising, Phase IIa trial. The study will include a dose escalation phase and a dose confirmation phase. In the dose escalation phase, NanoPac® concentrations of 6, 10, and 15 mg/mL in an injection volume of 20% of the lobe of the prostate containing the dominant lesion will be studied in cohorts of 3, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data the next cohort may begin enrolling, or an additional 3 at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the DSMB, will enroll additional subjects (dose confirmation phase) to provide a cohort of 12 subjects at that dose level.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 13, 2017
• Study Start: September 6, 2017
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)