(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer (PM-01)
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BTH1704
IMPRIME PGG
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, adenocarcinoma of the pancreas (PDAC), mixed adenocarcinoma of the pancreas, locally advanced, recurrent, metastatic
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 18 years
- Histologically or cytologically confirmed adenocarcinoma of the pancreas, including pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and ampulla of vater carcinoma,that is locally advanced (not able to proceed with surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is acceptable where the invasive component is predominantly adenocarcinoma)
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
- Has an ECOG PS of 0, 1, or 2
- Has been off chemotherapy for > or = 2 weeks
- Has a patent biliary stent if required for biliary ductal obstruction, has adequate nutritional intake, and pain which is stable for a minimum of 24 hrs (pain score ≤ 3/10)
- Has total bilirubin < 2 mg/dL, AST and ALT < 3.0 × ULN or < 5 x ULN for subjects with known hepatic metastases
- Has serum creatinine < 2.5 × ULN
- Has hemoglobin ≥ 9 g/dL, ANC ≥ 1.0 × 10^9/L, and platelet count ≥ 100 × 10^9/L
- Must be willing and able to comply with study
- Has read, understood and signed the ICF
- Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
- Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least 30 days after the last dose of study drug. Total abstinence is an acceptable alternative.
- Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
- Availability of tissue if applicable (from the primary tumor or metastases)for banking
- Willingness to donate blood for biomarker studies
- Must have received at least one prior systemic chemotherapy on which disease progressed
Exclusion Criteria:
- Has a diagnosis of resectable pancreatic adenocarcinoma
- Had surgery within 4 weeks prior to study treatment
- Has either untreated or symptomatic CNS mets
- Has a known hypersensitivity to BTH1704, murine proteins, or any component of BTH1704
- Has a known hypersensitivity to baker's yeast
- Has had previous exposure to Imprime PGG
- Has previously received an organ or progenitor/stem cell transplant
- Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
- Has a known history of HIV positivity or untreated & uncontrolled hepatitis B or C
- Has any clinically significant infection
- Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF or has a known or suspected allergy to the study drug
- Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation
- Presence of any non-healing wound, fracture, or ulcer
- Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
- Has any mental or medical condition that prevents the patient from giving informed consent
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to gemcitabine or drugs to formulate.
Sites / Locations
- UI Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMPRIME PGG, BTH1704, & Gemcitabine
Arm Description
Imprime PGG with BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day cycle with Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day cycle.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD)
The primary objective of this Phase 1b study is to determine the maximal administered dose (MAD) of BTH1704 (Mucin-1 targeted antibody) in combination with gemcitabine and Imprime PGG (beta 1,3/1,6 glucan) when given to patients with advanced and previously treated pancreatic ductal adenocarcinoma (PDAC).
Secondary Outcome Measures
Adverse Effects
Characterize adverse effects (AE) of I-BTH-Gem in patients with advanced PDAC in the second and third line setting.
Disease Response based on RECIST Criteria
Evaluate clinical response of I-BTH-Gem in patients with advanced PDAC in the second and third line setting (RECIST v 1.1).
Full Information
NCT ID
NCT02132403
First Posted
May 5, 2014
Last Updated
April 29, 2015
Sponsor
University of Illinois at Chicago
Collaborators
HiberCell, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02132403
Brief Title
(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
Acronym
PM-01
Official Title
PM-01: Phase 1b Study of PGG Beta Glucan (Imprime PGG®) in Combination With Anti-MUC1 Antibody (BTH1704) and Gemcitabine (Gemzar®) for the Treatment of Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Drug Recall
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
HiberCell, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard "3+3" design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, adenocarcinoma of the pancreas (PDAC), mixed adenocarcinoma of the pancreas, locally advanced, recurrent, metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMPRIME PGG, BTH1704, & Gemcitabine
Arm Type
Experimental
Arm Description
Imprime PGG with BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day cycle with Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
BTH1704
Other Intervention Name(s)
Humanized Human Milk Fat Globule 1 Antibody, huHMFG1, R1550, AS1402, Therex
Intervention Description
BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
Intervention Type
Drug
Intervention Name(s)
IMPRIME PGG
Other Intervention Name(s)
Beta 1,3/1,6 glucan
Intervention Description
Imprime PGG at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar®
Intervention Description
Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day (4 week) cycle.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
The primary objective of this Phase 1b study is to determine the maximal administered dose (MAD) of BTH1704 (Mucin-1 targeted antibody) in combination with gemcitabine and Imprime PGG (beta 1,3/1,6 glucan) when given to patients with advanced and previously treated pancreatic ductal adenocarcinoma (PDAC).
Time Frame
Up to 30 days post last dose
Secondary Outcome Measure Information:
Title
Adverse Effects
Description
Characterize adverse effects (AE) of I-BTH-Gem in patients with advanced PDAC in the second and third line setting.
Time Frame
Up to 30 days post final dose
Title
Disease Response based on RECIST Criteria
Description
Evaluate clinical response of I-BTH-Gem in patients with advanced PDAC in the second and third line setting (RECIST v 1.1).
Time Frame
Up to 8 weeks following final dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 years
Histologically or cytologically confirmed adenocarcinoma of the pancreas, including pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and ampulla of vater carcinoma,that is locally advanced (not able to proceed with surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is acceptable where the invasive component is predominantly adenocarcinoma)
Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
Has an ECOG PS of 0, 1, or 2
Has been off chemotherapy for > or = 2 weeks
Has a patent biliary stent if required for biliary ductal obstruction, has adequate nutritional intake, and pain which is stable for a minimum of 24 hrs (pain score ≤ 3/10)
Has total bilirubin < 2 mg/dL, AST and ALT < 3.0 × ULN or < 5 x ULN for subjects with known hepatic metastases
Has serum creatinine < 2.5 × ULN
Has hemoglobin ≥ 9 g/dL, ANC ≥ 1.0 × 10^9/L, and platelet count ≥ 100 × 10^9/L
Must be willing and able to comply with study
Has read, understood and signed the ICF
Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least 30 days after the last dose of study drug. Total abstinence is an acceptable alternative.
Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
Availability of tissue if applicable (from the primary tumor or metastases)for banking
Willingness to donate blood for biomarker studies
Must have received at least one prior systemic chemotherapy on which disease progressed
Exclusion Criteria:
Has a diagnosis of resectable pancreatic adenocarcinoma
Had surgery within 4 weeks prior to study treatment
Has either untreated or symptomatic CNS mets
Has a known hypersensitivity to BTH1704, murine proteins, or any component of BTH1704
Has a known hypersensitivity to baker's yeast
Has had previous exposure to Imprime PGG
Has previously received an organ or progenitor/stem cell transplant
Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
Has a known history of HIV positivity or untreated & uncontrolled hepatitis B or C
Has any clinically significant infection
Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF or has a known or suspected allergy to the study drug
Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation
Presence of any non-healing wound, fracture, or ulcer
Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
Has any mental or medical condition that prevents the patient from giving informed consent
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to gemcitabine or drugs to formulate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Venepalli, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
UI Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
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