Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab, CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Status: | Active, not recruiting |
---|---|
Conditions: | Liver Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | September 12, 2017 |
End Date: | February 29, 2020 |
A Phase 1b, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Subjects With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in
combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and
atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).
combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and
atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).
The study will have a Run-in portion and an Expansion portion. The Run-in portion will be
used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to
evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with
CISGEM treatment in the Expansion portion of the study. Treatment in both portions of the
study will continue until death, withdrawal of consent from the study, disease progression,
or unacceptable toxicity.
used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to
evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with
CISGEM treatment in the Expansion portion of the study. Treatment in both portions of the
study will continue until death, withdrawal of consent from the study, disease progression,
or unacceptable toxicity.
Inclusion Criteria:
For both portions of the study, participants must satisfy all of the following inclusion
criteria to be enrolled in the study:
- Written Institutional Review Board/Ethics Committee-approved informed consent form
(ICF), signed by participant or legally authorized representative.
- Participants must be determined to have histologically confirmed unresectable, locally
advanced or metastatic adenocarcinoma of the intra- and/or extra-hepatic bile ducts
and/or gallbladder. Participants must have sufficient tissue with architectural
integrity, including tumor and associated stroma, available for retrospective
biomarker testing.
- One or more lesions measurable on computed tomography (CT) scan/magnetic resonance
imaging (MRI) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version
1.1 (v1.1).
- Participants having Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
to 1.
- Life expectancy ≥3 months.
- Males and females aged ≥18 years.
- Screening clinical laboratory values within pre-determined parameters
- Female participants of childbearing potential (WOCBP) must have a negative urine or
serum pregnancy test within 7 days before Day 1 (first dose of study medication).
- For WOCBP and for men, agreement to use a highly effective contraceptive method from
the time of screening throughout the study until 5 months (WOCBP) or 6 months (men)
after administration of the last dose of any study medication. Highly effective
contraceptive methods consist of prior sterilization, intrauterine device (IUD),
intrauterine hormone releasing system (IUS), oral or injectable contraceptives,
barrier methods, and/or true sexual abstinence.
Exclusion Criteria:
Participants are ineligible for enrollment if they meet any of the following exclusion
criteria:
- Clinical evidence of deep vein thrombosis or pulmonary embolism present during the
screening period
- New York Heart Association Class III or IV cardiac disease, atrial fibrillation,
unstable angina, or myocardial infarction within the past 12 months before screening.
- Participants with known brain metastases
- History of cerebrovascular accident or transient ischemic attack
- History of active bleeding within the last 3 months prior to screening requiring
transfusion.
- Participants must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for treatment of metastatic or locally advanced disease.
- Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B
surface antigen (HBsAg) test at screening
- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody
test at screening
- History of:
1. Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest CT scan. History of radiation pneumonitis
in the radiation field (fibrosis) is permitted.
2. Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis,
primary sclerosing cholangitis, history of immune-mediated cholangitis);
Participants with cholangitis attributed to infectious etiology (e.g., ascending
cholangitis, bacterial cholangitis) are eligible if the infection has been fully
resolved prior to the screening visit.
3. Or known cases of drug-induced hepatobiliary toxicities.
- Active or history of autoimmune diseases
- Uncontrolled hypercalcemia
We found this trial at
30
sites
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Andrea Bullock
Phone: 617-975-7409
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Marcus Noel
Phone: 585-233-4310
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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825 Eastlake Ave E
Seattle, Washington 98109
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Bill Harris
Phone: 206-606-7350
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Ann Arbor, Michigan 48109
Principal Investigator: Vaibhav Sahai
Phone: 734-232-0744
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Adrian Murphy
Phone: 973-754-3811
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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4875 Higbee Ave NW
Canton, Ohio 44718
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Gabrail
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Carolyn Britten
Phone: 843-792-9007
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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20 Duke Clinic Cir
Durham, North Carolina 27710
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Michael Morse
Phone: 919-668-1861
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Houston, Texas 77030
Principal Investigator: Kanwal Raghav
Phone: 713-792-0240
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Fadi Braiteh
Phone: 702-952-3446
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Anthony El-Khoueiry
Phone: 323-865-0467
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Milwaukee, Wisconsin 53226
Principal Investigator: Paul Ritch
Phone: 414-805-3645
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333 Cedar Street
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Stacey Stein
Phone: 203-785-6661
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New York, New York 10065
Principal Investigator: Ghassan Abou-Alfa
Phone: 646-888-4330
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1001 Health Sciences Road
Orange, California 92868
Orange, California 92868
Principal Investigator: Farshid Dayyani
Phone: 714-456-5153
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
(412) 647-2811
Principal Investigator: Nathan Bahary
Phone: 412-623-4870
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Kian-Huant Lim
Phone: 314-286-2585
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
Principal Investigator: Ignacio Garrido
Phone: 801-587-4624
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Santa Monica, California 90404
Principal Investigator: Randy Hecht
Phone: 888-662-8252
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Seattle, Washington 98111
Principal Investigator: Vincent Picozzi
Phone: 206-341-8993
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Seoul, Gangnam-gu 135-230
Principal Investigator: Joon Oh Park
Phone: 82-2148-7396
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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Washington, District of Columbia 02007
Principal Investigator: Aiwu He
Phone: 202-687-2939
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Whittier, California 90606
Principal Investigator: Omkar Marathe
Phone: 562-693-2299
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