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Trial record 3 of 4 for:    nanopac

Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

This study is currently recruiting participants.
Verified October 2017 by NanOlogy, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03077659
First Posted: March 13, 2017
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC
  Purpose
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.

Condition Intervention Phase
Adenocarcinoma of the Prostate Drug: NanoPac® Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Dose Escalation Trial of NanoPac® Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by NanOlogy, LLC:

Primary Outcome Measures:
  • Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to Day 29 (time of prostatectomy) ]
    Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.


Secondary Outcome Measures:
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® [ Time Frame: Up to Day 29 (time of prostatectomy) ]
    Pharmacokinetic (PK) samples will be taken on Day 1 at 1, 2, 4, and 6 hours post-injection and weekly until prostatectomy (Day 29).

  • Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® [ Time Frame: Up to Day 29 (time of prostatectomy) ]
    Pharmacokinetic (PK) samples will be taken on Day 1 at 1, 2, 4, and 6 hours post-injection and weekly until prostatectomy (Day 29).

  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® [ Time Frame: Up to Day 29 (time of prostatectomy) ]
    Pharmacokinetic (PK) samples will be taken on Day 1 at 1, 2, 4, and 6 hours post-injection and weekly until prostatectomy (Day 29).

  • Tumor response based on change in image volume on mpMRI [ Time Frame: Three months prior to consent and Day 29 ]
    Tumor response to treatment with NanoPac® will be 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).

  • Tumor response based on histologic evaluation of biopsied prostate samples [ Time Frame: Baseline and Day 29 (time of prostatectomy) ]
    Prostate tissue samples will be obtained via biopsy at baseline and immediately prior to prostatectomy (Day 29). Histologic evaluation of these samples will be used to evaluate the tumor response to treatment with NanoPac®.

  • Presence of tumor cells in tissues obtained at prostatectomy (Day 29) [ Time Frame: Day 29 (prostatectomy) ]
    Tissues excised during prostatectomy (Day 29) will be evaluated for the presence of tumor cells; tissues to be evaluated include the ipsilateral lobe of the prostate, the contralateral lobe of the prostate, and pelvic lymph nodes.


Estimated Enrollment: 30
Actual Study Start Date: September 6, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NanoPac® 6 mg/mL
NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
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.
Other Name: Paclitaxel
Experimental: NanoPac® 10 mg/mL
NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
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.
Other Name: Paclitaxel
Experimental: NanoPac® 15 mg/mL
NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
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.
Other Name: Paclitaxel

Detailed Description:

In this open-label, dose rising, Phase IIa trial with an expanded cohort at the dose of NanoPac® determined to have the best tolerability and safety profile, subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy. 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 to provide a cohort of 12 subjects at that dose level.

Tumor volume and serum prostate-specific antigen (PSA) will be determined prior to NanoPac® injection. Pharmacokinetic samples, PSA, and ejaculate will be collected in the interval between injection and prostatectomy. Imaging with mpMRI will be performed prior to NanoPac® injection and prior to prostatectomy. Prostate and pelvic lymph nodes excised at prostatectomy will be evaluated.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077659


Contacts
Contact: Shelagh Verco, PhD 805-595-1300 shelagh.verco@usbiotest.com
Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana, MPH    323-865-0702    ileana.aldana@med.usc.edu   
Principal Investigator: Inderbir Gill, MD         
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
Study Director: Shelagh Verco, PhD US Biotest, Inc.
  More Information

Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03077659     History of Changes
Other Study ID Numbers: NANOPAC-2016-02
First Submitted: February 28, 2017
First Posted: March 13, 2017
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NanOlogy, LLC:
prostate cancer
prostatic neoplasms
genital neoplasms, male
urogenital neoplasms
prostatic diseases

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type