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| Name | Class |
|---|---|
| US Biotest, Inc. | INDUSTRY |
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This study will evaluate NanoPac® administered intraperitoneally (IP) immediately post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with SOC IV chemotherapy alone.
Research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal [IP] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy.
This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac® administered immediately post-cytoreductive surgery in women with ovarian cancer. In the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses from the dose-finding phase will be determined. In the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoPac® 100 mg/m2 | Experimental | Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
|
| NanoPac® 200 mg/m2 | Experimental | Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
|
| NanoPac® 300 mg/m2 | Experimental | Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
|
| NanoPac® 400 mg/m2 | Experimental | Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. |
|
| Standard of Care Intravenous Chemotherapy | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoPac® 100 mg/m2 | Drug | Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events | Adverse events will include any clinically relevant changes in laboratory values, vital signs, and physical examination. Treatment-emergent adverse events occur when the date and time of the adverse event onset is on or after the first application of the investigational agent and any time up to when the intravenous chemotherapy commences. Treatment-emergent adverse events will be summarized for each treatment group. The summaries will include an overall summary of the number of subjects reporting and the number of events reported, summaries of adverse events leading to termination or death, and summaries by severity and relatedness (separately and combined). Of greatest interest will be post-surgery signs of toxicity (e.g., severe abdominal pain after 5-7 days, neutropenia, thrombocytopenia, bowel dehiscence, prolonged ileus). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration of Paclitaxel (Cmax) | Plasma samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-intraperitoneal administration of NanoPac® and weekly thereafter until IV chemotherapy begins. Additionally, a pharmacokinetics (PK) sample will be collected from every subject prior to each cycle of IV chemotherapy for determination of paclitaxel concentrations to assess potential NanoPac® persistence. PK levels of paclitaxel in the plasma will be summarized descriptively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Walker, MD | University of Oklahoma | Principal Investigator |
| Gere diZerega, MD | US Biotest, Inc./NanOlogy, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Greater Baltimore Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | NanoPac® 100 mg/m2 | Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2019 | Feb 3, 2021 |
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Standard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards.
|
| NanoPac® 200 mg/m2 | Drug | Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
|
| NanoPac® 300 mg/m2 | Drug | Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
|
| NanoPac® 400 mg/m2 | Drug | Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
|
| Standard of Care Intravenous Chemotherapy | Drug | Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
|
| 12 months |
| Progression Free Survival (PFS) at 12 Months | Progression free survival (PFS) was assessed every 3 months until the end of the 12-month follow-up period, and every 6 months thereafter until progression or the last subject in the trial has completed 12 months of follow-up. Factors taken into account to determine time-to-progression included CA-125 levels, tumor burden as assessed by imaging and utilizing RECIST version 1.1 for assessment of response, and cancer-related symptoms such as bowel obstruction and ascites. | 12 months post-treatment |
| Baltimore |
| Maryland |
| 21204 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| SUNY Downstate | Brooklyn | New York | 11203 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| FG001 | NanoPac® 200 mg/m2 | Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NanoPac® 100 mg/m2 | Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
| BG001 | NanoPac® 200 mg/m2 | Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Disease Status | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Status | ECOG Performance Scale: 0 Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
| |||||||||||||||
| Status of Ovarian Cancer at Screening | Ovarian cancer stages range from stage I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means cancer has spread more. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-emergent Adverse Events | Adverse events will include any clinically relevant changes in laboratory values, vital signs, and physical examination. Treatment-emergent adverse events occur when the date and time of the adverse event onset is on or after the first application of the investigational agent and any time up to when the intravenous chemotherapy commences. Treatment-emergent adverse events will be summarized for each treatment group. The summaries will include an overall summary of the number of subjects reporting and the number of events reported, summaries of adverse events leading to termination or death, and summaries by severity and relatedness (separately and combined). Of greatest interest will be post-surgery signs of toxicity (e.g., severe abdominal pain after 5-7 days, neutropenia, thrombocytopenia, bowel dehiscence, prolonged ileus). | Posted | Number | Treatment Emergent Adverse Events | 12 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration of Paclitaxel (Cmax) | Plasma samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-intraperitoneal administration of NanoPac® and weekly thereafter until IV chemotherapy begins. Additionally, a pharmacokinetics (PK) sample will be collected from every subject prior to each cycle of IV chemotherapy for determination of paclitaxel concentrations to assess potential NanoPac® persistence. PK levels of paclitaxel in the plasma will be summarized descriptively. | Posted | Mean | Standard Deviation | ng/mL | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) at 12 Months | Progression free survival (PFS) was assessed every 3 months until the end of the 12-month follow-up period, and every 6 months thereafter until progression or the last subject in the trial has completed 12 months of follow-up. Factors taken into account to determine time-to-progression included CA-125 levels, tumor burden as assessed by imaging and utilizing RECIST version 1.1 for assessment of response, and cancer-related symptoms such as bowel obstruction and ascites. | Of the 10 subjects enrolled, four subjects were not evaluable for PFS at 12 months post-NanoPac instillation. For one subject, no imaging was performed over the course of the study; one subject was deceased due to leptomeningeal carcinomatosis; one subject was deceased due to a respiratory arrest; and one subject withdrew consent from the study. Both deaths were considered not related to study medication by the Investigator and the Medical Monitor. | Posted | Count of Participants | Participants | 12 months post-treatment |
|
AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NanoPac® 100 mg/m2 | Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment | 1 | 7 | 4 | 7 | 7 | 7 |
| EG001 | NanoPac® 200 mg/m2 | Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment | 1 | 3 | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pelvic fluid collection | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Wound necrosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Major depression | Psychiatric disorders | Systematic Assessment |
| ||
| Pelvic abscess | Infections and infestations | Systematic Assessment |
| ||
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal Reflux | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus paralytic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Administration site extravasation | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood albumin decreased | Investigations | Systematic Assessment |
| ||
| Blood chloride decreased | Investigations | Systematic Assessment |
| ||
| Blood urea decreased | Investigations | Systematic Assessment |
| ||
| Glomerular filtration rate decreased | Investigations | Systematic Assessment |
| ||
| Haematocrit decreased | Investigations | Systematic Assessment |
| ||
| Heart rate irregular | Investigations | Systematic Assessment |
| ||
| Lymphocyte count | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
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| Protein total decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalacaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Pelvic fluid collection | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
Early termination leading to small numbers of subjects analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gere S. diZerega, MD, Responsible Medical Officer | US Biotest, Inc. | 1-805-595-1300 | gere.dizerega@usbiotest.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2020 | Feb 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Recurrent |
|
| ECOG 1 |
|
| IIIB |
|
| IIIC |
|
| IVB |
|
|
|
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy. NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment |
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