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Sponsorship for trial was halted after company acquisition
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This research study is evaluating a study drug to treat pancreatic exocrine insufficiency (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is recovering from surgery and receiving adjuvant treatment.
The study drug involved in this study is:
-Zenpep
The FDA (the U.S. Food and Drug Administration) has approved Zenpep as a treatment option for PEI. Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.
In this research study, the investigators are studying whether Zenpep will improve the ability of patients to complete adjuvant treatment for their pancreatic cancer after surgery to remove their tumor. The investigators are also studying if Zenpep will have an effect on nutrition status and quality of life for pancreatic cancer patients after they have had surgery to remove their tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zenpep | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancrelipase | Drug | Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer | Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer | Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84 | 84 days after surgery |
| Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count |
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Inclusion Criteria:
Participants must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Variants or mixed histology will be included if the predominant histology is adenocarcinoma.
Participants must have potentially resectable pancreatic cancer defined as: (1) no detectable metastases (2) signed consent for attempted resection of pancreatic cancer per treating surgeon.
ECOG performance status ≤2.
Age >18 years. Participants <18 years old are excluded from this study because subsequent adjuvant therapy is based on therapy guidelines in the adult population.
Willingness to consider adjuvant therapy following surgical resection of disease, signed in the consent form attestation.
Ability to understand and willingness to provide written informed consent.
Pre-operative laboratory values adequate to undergo resection of pancreatic cancer, as defined below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur James Moser, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zenpep |
Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to company acquisition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zenpep |
Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer | Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 40 weeks |
|
52 weeks after drug initiation and until patient began adjuvant chemotherapy or adjuvant radiation.
The definition of adverse events and/or serious adverse events does not differ from clinicaltrials.gov.
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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 | Zenpep |
Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer. |
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Early termination per sponsor leading to small numbers of subjects enrolled. Those subjects who were enrolled did not meet pathologic criteria to remain on study and would have been replaced had the study continued.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. James Moser, MD | Beth Israel Deaconess Medical Center | (617) 632-1032 | ajmoser@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2019 | Jul 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
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|
|
Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen |
| 52 weeks |
| Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer | Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen | 52 weeks |
| Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer | Quantify serum albumin (g/dl ) to correlate pancreatic enzyme replacement therapy with nutrition status before and after surgery and adjuvant therapy for early stage pancreatic cancer | 52 weeks |
| Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer | Measure body weight (in kg) at regular intervals throughout study participation to investigate whether pancreatic enzyme replacement therapy improves nutrition status during surgery and adjuvant treatment for early stage pancreatic cancer | 52 weeks |
| Evaluate Quality of Life Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer Using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Questionnaire | Subjects to complete EQ-5D-5L at regular intervals throughout study participation. The scale consists of 5 questions, one each to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has answers ranging from No Problems (level 1) to Extreme Problems (level 5). Subjects also to rate their overall health on a given day using the EuroQoL Visual Analog Scale (EQ-VAS) as a part of the EQ-5D-5L, which consists of marking on a visual scale from 0-100 (with 100 being best imaginable health and 0 being worst health imaginable). | 52 weeks |
| Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer | Incidence and severity of postoperative complications graded by Clavien-Dindo classification | 84 days after surgery |
| Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer | Standard grip strength dynamometer measurements at regular intervals throughout the study | 52 weeks |
|
| Age, Continuous | years |
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| Participant must be a candidate for standard of care adjuvant treatment according to their treating |
|
| Secondary | Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer | Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84 | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 84 days after surgery |
|
|
| Secondary | Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count | Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 52 weeks |
|
|
| Secondary | Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer | Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 52 weeks |
|
|
| Secondary | Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer | Quantify serum albumin (g/dl ) to correlate pancreatic enzyme replacement therapy with nutrition status before and after surgery and adjuvant therapy for early stage pancreatic cancer | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 52 weeks |
|
|
| Secondary | Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer | Measure body weight (in kg) at regular intervals throughout study participation to investigate whether pancreatic enzyme replacement therapy improves nutrition status during surgery and adjuvant treatment for early stage pancreatic cancer | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 52 weeks |
|
|
| Secondary | Evaluate Quality of Life Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer Using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Questionnaire | Subjects to complete EQ-5D-5L at regular intervals throughout study participation. The scale consists of 5 questions, one each to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has answers ranging from No Problems (level 1) to Extreme Problems (level 5). Subjects also to rate their overall health on a given day using the EuroQoL Visual Analog Scale (EQ-VAS) as a part of the EQ-5D-5L, which consists of marking on a visual scale from 0-100 (with 100 being best imaginable health and 0 being worst health imaginable). | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 52 weeks |
|
|
| Secondary | Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer | Incidence and severity of postoperative complications graded by Clavien-Dindo classification | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 84 days after surgery |
|
|
| Secondary | Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer | Standard grip strength dynamometer measurements at regular intervals throughout the study | Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition. | Posted | 52 weeks |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |