Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Pancreatic Diseases

Digestive System Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® administrations, with the second injection administered one month after the first injection.

Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the third phase will be determined during the dose escalation phase. Subjects will receive four NanoPac® administrations, with the injections administered one month apart.

Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.

NanoPac®

Shelagh Verco, PhD

Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.

In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.

Subjects will be enrolled in sequential cohorts of NanoPac® at escalating doses, at a volume based on up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects 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 most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the Data Safety Monitoring Board (DSMB), will be the dose used in the second phase of the study which will enroll 22 additional subjects who will receive two injections of NanoPac® at the same dose one month apart. In the third phase of the study, up to 30 subjects will receive up to four injections of NanoPac at the same dose, one month apart.

Plasma samples will be taken at various time points on the day of NanoPac® injection as well as once at each of the study visits, to characterize the pharmacokinetics (PK) of intratumoral NanoPac®.

Subjects will be followed for 12 months after NanoPac® injection for safety, overall survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen (CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging).

Open-label, dose-escalating, Phase IIa trial. Subjects will be enrolled in sequential cohorts of NanoPac® at a volume up to 20% of tumor volume (maximum injection volume of 5 mL per subject). Each cohort will have 3 subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling. The highest dose with an acceptable safety and tolerability profile will be the dose used in the second phase of the study which will enroll 22 additional subjects to receive 2 NanoPac® injections one month apart and 30 additional subjects to receive 4 NanoPac® injections one month apart.

Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection

Tumor burden at 3 months after NanoPac® injection will be compared with baseline tumor burden.

Pain scores will be measured using a visual analog scale

Tumor markers measured will include CEA and CA19-9

US Biotest, Inc.

NanOlogy, LLC

Symptoms and General Pathology

Cysts

Pancreatic Cyst

Mucocele

Neoplasms, Cystic, Mucinous, and Serous

Endocrine Gland Neoplasms

Endocrine System Diseases

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

This study will evaluate intracystic NanoPac® (Sterile Nanoparticulate Paclitaxel) administered via endoscopic ultrasound-guided fine needle injection (EUS-FNI) in subjects with mucinous cystic pancreatic neoplasms.

In this open-label, dose rising trial, subjects with mucinous cystic pancreatic neoplasms will receive intracystic NanoPac® via endoscopic ultrasound-guided fine needle injection (EUS-FNI).

In the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac® at 6, 10, and 15 mg/mL at volumes sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following Data Safety Monitoring Board (DSMB) review of the cohort data, the next cohort may begin enrolling, an additional three 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 be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection..

Plasma samples will be taken on the day(s) of NanoPac® injection at 1 and 2 hours after injection, as well as at each of the subsequent study visits, to characterize the pharmacokinetics (PK) of intracystic NanoPac®.

Subjects will be followed for 6 months after the first NanoPac® injection for safety, tolerability and cyst response to therapy (as shown by imaging).

Open-label, dose rising trial. During the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac®. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects 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 be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection.

Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Dose Escalation: NanoPac® 6 mg/mL

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Dose Escalation: NanoPac® 10 mg/mL

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Dose Escalation: NanoPac® 15 mg/mL

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Body Mass Index (BMI) (kg/m2)

All enrolled subjects (n=20) who received at least one NanoPac injection (n=19) were designated as the Safety Population, and included in the analysis population for all outcome analyses. The subject who withdrew consent prior to any NanoPac treatment is not included in the analysis population.

Gere S. diZerega, MD

Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)

Screening

Week 12

Week 24/EOS

In the dose escalation phase, baseline imaging data for the measurement of cyst diameters and calculation of cyst volume was available in all subjects. At Week 12, 18 of 19 subjects had three cyst diameters available for analyses. At Week 24, 17 of 19 subjects had three cyst diameters available for analyses.

Cyst Volume Response

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Urogenital Neoplasms

Prostatic Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

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

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

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

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.

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.

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.

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.

Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

Phase IIa Dose Escalation Trial of NanoPac® Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

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.

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.

Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma

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.

Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.

NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.

NanoPac® 6 mg/mL

NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.

NanoPac® 10 mg/mL

NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.

NanoPac® 15 mg/mL

United States

Region of Enrollment

All TEAEs

Possibly Related TEAEs

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

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.

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

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.

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

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.

Lesion Volume at Screening

Lesion Volume at Day 29

Tumor Response Based on Change in Image Volume on mpMRI

Gleason Score at Screening

Gleason Score at Day 29

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

Primary Tumor at Screening

Primary Tumor at Day 29

Percentage of Sample Considered Adenocarcinoma

Day 1 - 1 hr Post-Injection

Day 1 - 2 hr Post-Injection

Day 1 - 4 hr Post-Injection

Day 1 - 6 hr Post-Injection

Day 8

Day 15

Day 22

Day 29

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

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

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

Concentration of Paclitaxel in the Systemic Circulation

PSA Density at Screening

PSA Density at Day 29

Change in PSA Density

PI-RADS 3 : Screening

PI-RADS 3 : Day 29

PI-RADS 4 : Screening

PI-RADS 4 : Day 29

PI-RADS 5 : Screening

PI-RADS 5 : Day 29

The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of a prostate malignancy. PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present); PI-RADS 2: low (clinically significant cancer is unlikely to be present); PI-RADS 3: intermediate (presence of clinically significant cancer is equivocal); PI-RADS 4: high (clinically significant cancer is likely to be present); PI-RADS 5: very high (clinically significant cancer is highly likely to be present).

Change in PI-RADS Score

Any invasion at Screening? Yes

Any invasion at Screening? No

Any invasion at Day 29? Yes

Any invasion at Day 29? No

Assessed histologically after TRUS biopsy at Screening and on Day 29 prior to prostatectomy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma	NCT03077685	Locally Advance...	NanoPac®	18 Years -	NanOlogy, LLC
Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms	NCT03188991	Pancreatic Muci...	NanoPac®	18 Years -	NanOlogy, LLC
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer	NCT03077659	Adenocarcinoma ...	NanoPac®	18 Years -	NanOlogy, LLC

Spots Global Cancer Trial Database for nanopac®

Every month we try and update this database with for nanopac® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nanopac®

Every month we try and update this database with for nanopac® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nanopac® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.