Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 December 2021 |
Main ID: |
EUCTR2015-004068-13-HU |
Date of registration:
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18/02/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
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Scientific title:
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma |
Date of first enrolment:
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12/04/2016 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004068-13 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Brazil
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Canada
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China
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Croatia
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Czech Republic
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Denmark
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Estonia
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France
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Germany
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Hungary
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Israel
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Netherlands
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Poland
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Halozyme Study Information
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Address:
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11388 Sorrento Valley Road
92121
San Diego
United States |
Telephone:
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+18448554256 |
Email:
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medinfo@halozyme.com |
Affiliation:
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Halozyme, Inc. |
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Name:
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Halozyme Study Information
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Address:
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11388 Sorrento Valley Road
92121
San Diego
United States |
Telephone:
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+18448554256 |
Email:
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medinfo@halozyme.com |
Affiliation:
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Halozyme, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Signed, written Institutional Review Board/Ethics Committee
approved Informed Consent Form (ICF).
2. Stage IV PDA with histological or cytological confirmation of PDA
3. Subjects must be determined to be HA-high based on archived or fresh
tumor core biopsy or sample obtained after the subject has documented
metastatic disease. Biopsies/samples must meet the following
requirements:
a. Pancreas tumor biopsies/samples obtained on or after the date that
metastatic disease is documented or tumor biopsies/samples from a
metastatic lesion are acceptable.
b. Tumor biopsies or samples must meet the requirements provided in
the Study Laboratory Manual with regard to tumor tissue architecture.
Note: cytology samples from fine needle aspirates without maintained
tissue architecture or brushing biopsies are not acceptable.
c. Tumor tissue (formalin-fixed paraffin-embedded [FFPE] block
preferred) must include enough tumor to make a minimum of 5-10
unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival
block that meet specific tissue sample requirements (see Study
Laboratory Manual). Radiographic confirmation.
4. Radiographic confirmation of Stage IV PDA with at least 1 tumor
metastasis measurable on CT scan or MRI per RECIST version 1.1
criteria, excluding the primary pancreatic lesion.
5.If a subject has had adjuvant/neoadjuvant therapy and/or therapy for
locally advanced disease (chemotherapy for non-metastatic pancreatic
cancer in combination with or without radiation therapy), tumor
recurrence or disease progression must have occurred no sooner than 6
months after completing the last dose of the aforementioned therapies,
provided all toxicities have returned to baseline or = Grade 1.
6. Eastern Cooperative Oncology Group Performance Status of 0 or 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 253 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 247
Exclusion criteria: 1. Clinical evidence of DVT, PE or other known TE event present during the screening period.
2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
3. Known central nervous system involvement or brain metastases.
4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
5. History of cerebrovascular accident or transient ischemic attack.
6. Clinically significant pre-existing carotid artery disease.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma MedDRA version: 20.0
Level: LLT
Classification code 10007050
Term: Cancer
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: PEGylated Recombinant Human Hyaluronidase Product Code: PEGPH20 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Proposed INN currently under review: pegvorhyaluronidase alfa CAS Number: 1620390-06-8 Current Sponsor code: PEGPH20 Other descriptive name: PEGylated Recombinant Human Hyaluronidase Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.30- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Trade Name: ABRAXANE Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Paclitaxel bound to human albumin CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-
Trade Name: Gemcitabine 38 mg/ml Concentrate for Solution for Infusion Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: gemcitabine hydrochloride CAS Number: 122111-03-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 38-
Trade Name: Gemcitabine 38 mg/ml Concentrate for Solution for Infusion Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Gemcitabine hydrochloride CAS Number: 122111-03-9 Other descriptive name: GEMCITABINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 38-
Trade Name: Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Gemcitabine hydrochloride CAS Number: 122111-03-9 Other descriptive name: GEMCITABINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal
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Primary Outcome(s)
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Secondary Objective: To determine the PFS benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA
To determine the ORR and DOR of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA
To assess the safety and tolerability of PAG treatment in subjects with HA-high Stage IV previously untreated PDA
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Main Objective: To determine the OS benefit of PEGPH20 combined with NAB plus GEM (PAG treatment), compared with placebo plus NAB/GEM (AG treatment), in subjects with HA-high Stage IV previously untreated PDA
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Timepoint(s) of evaluation of this end point: Refer to protocol for information.
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Primary end point(s): Overall survival
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Secondary Outcome(s)
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Secondary end point(s): • Progression-free survival
• Objective response rate
• Duration of response
• Incidence of AEs, changes in clinical safety laboratory values, and changes in cardiovascular parameters (electrocardiogram [ECG] and vital signs)
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Timepoint(s) of evaluation of this end point: Refer to protocol for information.
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Secondary ID(s)
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NCT02715804
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HALO-109-301
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2015-004068-13-LV
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Source(s) of Monetary Support
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Halozyme, Inc.
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Ethics review
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Status: Approved
Approval date: 30/03/2016
Contact:
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