Pancreatic CancerPhase 2NCT03816163
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
A Phase 2 study testing zolbetuximab, nab-paclitaxel and gemcitabine in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Astellas Pharma Global Development, Inc. at 136 sites in 13 countries.
Trial summary
Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- zolbetuximab, nab-paclitaxel and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 136 sitesin 13 countries
- Study dates
- 15 Mar 2019to 31 Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
- A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
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- A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
- Subject agrees not to participate in other interventional studies while receiving study drug in present study.
- Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.
- Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy.
- Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed
- If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy.
- Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible.
- Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
- Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject has predicted life expectancy ≥ 12 weeks.
- Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used.
- Hemoglobin ≥ 9 g/dl (no transfusion within 14 days of start of study treatment)
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Albumin ≥ 2.5 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (≤ 5 x ULN if liver metastases are present)
- Estimated creatinine clearance ≥ 30 mL/min
- Prothrombin time/international normalized ratio (INR) and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)
Who cannot join
- Subject has received other investigational treatment within 28 days prior to randomization.
- Subject has received radiotherapy for metastatic pancreatic adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.
- Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
- Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies.
- Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
- Subject has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs antigen [Ag]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.
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- For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded.
- Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible.
- Subjects treated for hepatitis C with undetectable viral load results are eligible.
- Subject has a history of interstitial pneumonia or pulmonary fibrosis.
- Subject has pleural effusion or ascites ≥ Grade 3.
- Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization.
- Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomization.
- Subject has significant cardiovascular disease, including:
- Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization;
- History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
- QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects;
- Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.)
- Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma.
- Subject has known peripheral sensory neuropathy ≥ Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality.
- Subject has had a major surgical procedure ≤ 28 days prior to randomization.
- Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
- Psychiatric illness or social situations that would preclude study compliance.
- Subject has another malignancy for which treatment is required.
- Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Trial locations and contacts
136 sites in 13 countries.
136 sites in 13 countries
United States25 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Lynn Cancer Institute
Boca Raton, Florida, 33486
Roswell Park Cancer Institute
Buffalo, New York, 14203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
University of Illinois at Chicago
Chicago, Illinois, 60612
Memorial Sloan Kettering Commack
Commack, New York, 11725
David C Pratt Cancer Center
Creve Coeur, Missouri, 63141
St. Joseph Heritage Medical Group
Fullerton, California, 92835
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor, Washington, 98335
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Houston Methodist Hospital
Houston, Texas, 77030
Northwell Health Cancer Institute
Lake Success, New York, 11042
Norton Cancer Institute (NCI)
Louisville, Kentucky, 40202
Midstate Medical Center
Meriden, Connecticut, 06451
Baptist Health
Miami, Florida, 33176
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Ochsner Health System
New Orleans, Louisiana, 70121
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022
Cancer Treatment Centers of Atlanta
Newnan, Georgia, 30265
Vista Oncology
Olympia, Washington, 98502
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Virginia Mason
Seattle, Washington, 98101
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
TOI Clinical research
Whittier, California, 90603
Novant Health
Winston-Salem, North Carolina, 27103
China23 sites
Site CN86001
Beijing
Site CN86008
Beijing
Site CN86014
Beijing
Site CN86026
Changchun
Site CN86009
Chongqing
Site CN86004
Guangdong
Site CN86020
Guangdong
Site CN86016
Guangzhou
Site CN86012
Harbin
Site CN86002
Hubei
Site CN86005
Jiangsu
Site CN86011
Jiangsu
Site CN86025
Jiangsu
Site CN86023
Shandong
Site CN86006
Shanghai
Site CN86013
Shanghai
Site CN86019
Shanghai
Site CN86024
Shanxi
Site CN86007
Tianjin
Site CN86022
Xinjiang
Site CN86003
Zhejiang
Site CN86018
Zhejiang
Site CN86010
Zhengzhou
France19 sites
Site FR33003
Aquitaine, Pessac, 33604
Site FR33001
Bayonne, 64109
Site FR33008
Besançon, Besancon Cedex, 6XG7+42
Site FR33018
Bordeaux
Site FR33010
Brest, Brest Cedex, 9GV7+4G
Site FR33015
Caen, Cedex 5, 14076
Site FR33006
Chambray, Cedex 9, 37170
Site FR33002
Grenoble
Site FR33012
Herblain, Herblain Cedex, 44805
Site FR33016
La Chaussée-Saint-Victor, Loir-et-Cher, 41260
Site FR33019
La Roche-sur-Yon
Site FR33009
Nancy, Nancy Cedex, 54000
Site FR33021
Nice
Site FR33023
Pierre-Bénite
Site FR33014
Plérin, 22190
Site FR33005
Pringy, 74374
Site FR33017
Rouen, Normandy, 76000
Site FR33007
Strasbourg, 67000
Site FR33013
Villejuif, Villejuif Cedex, 94805
Spain15 sites
Site ES34010
Barcelona, 08028
Site ES34013
Barcelona, 08036
Site ES34007
Barcelona, 08916
Site ES34018
Barcelona
Site ES34021
Barcelona
Site ES34014
Cáceres, 10003
Site ES34022
Córdoba
Site ES34005
Lleida, 25198
Site ES34004
Llobregat, Barcelona, 08908
Site ES34015
Madrid, 28027
Site ES34006
Madrid, 28033
Site ES34009
Madrid, 28034
Site ES34026
Málaga
Site ES34003
Pamplona, Navarre, 31008
Site ES34017
Santiago de Compostela
Japan14 sites
Site JP81011
Bunkyo-ku, Tokyo
Site JP81012
Chuo-ku, Tokyo
Site JP81004
Fukuoka
Site JP81003
Kashihara, Nara
Site JP81001
Kashiwa, Chiba
Site JP81014
Koto-ku, Tokyo
Site JP81013
Mitaka, Tokyo
Site JP81007
Nagoya, Aichi-ken
Site JP81010
Osaka
Site JP81005
Sapporo, Hokkaido
Site JP81002
Shinjuku-ku, Tokyo
Site JP81015
Ube, Yamaguchi
Site JP81009
Wakayama
Site JP81006
Yokohama, Kanagawa
South Korea10 sites
Site KR82010
Daegu
Site KR82009
Gyeonggi-do
Site KR82005
Seongnam-si, Gyeonggi-do, 013620
Site KR82001
Seoul, 03080
Site KR82003
Seoul, 120-752
Site KR82004
Seoul, 138-736
Site KR82007
Seoul, 152-703
Site KR82002
Seoul, F3QP+76
Site KR82006
Seoul, G234+36
Site KR82008
Suwon, Gyeonggi-do
Italy7 sites
Site IT39004
Candiolo, Torino, 10060
Site IT39002
Cremona, 26100
Site IT39010
Lombardia
Site IT39003
Milan, 20141
Site IT39006
Rozzano, Milan, 20089
Site IT39014
Toscana
Site IT39008
Veneto
Brazil6 sites
Site BR55009
Centro Passo Fundo
Site BR55012
Porto Alegre, Rio Grande do Sul
Site BR55008
Rio Grande
Site BR55004
Santa Catarina
Site BR55010
São Paulo
Site BR55011
São Paulo
Turkey (Türkiye)5 sites
Site TR90004
Ankara
Site TR90006
Ankara
Site TR90003
Diyarbakır
Site TR90002
Istanbul
Site TR90001
Konya
Australia4 sites
Site AU61005
Fitzroy, Victoria, 5XRF+WX
Site AU61008
Gosford, New South Wales, NSW 2250
Site AU61006
Warrnambool, Victoria, VIC 3280
Site AU61007
Wollongong, New South Wales, HVGM+3C
Taiwan4 sites
Site TW88608
New Taipei City
Site TW88602
Taichung, 5M5J+36
Site TW88601
Taipei, 4G9C+W3
Site TW88609
Taipei
Mexico3 sites
Site MX52004
Distrito Federal
Site MX52003
San Luis Potosí City
Site MX52005
Veracruz
About this study
Official title: A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for people with pancreatic cancer.
There is an unmet medical need to treat people with pancreatic cancer. This study will help find the dose of zolbetuximab to be used with chemotherapy and provide more information on this treatment in adults with metastatic pancreatic cancer. The study is currently ongoing globally. People in this study will be treated with either zolbetuximab and chemotherapy or chemotherapy by itself.
Read more
The study's main aims are to find a suitable dose of zolbetuximab to be used with chemotherapy in the second part of this study, to check if zolbetuximab and chemotherapy compared to chemotherapy by itself can improve the survival of people with pancreatic cancer, and to check the safety of zolbetuximab when given with chemotherapy and how well people cope with medical problems during the study.
Adults with metastatic pancreatic cancer can take part. Their cancer is metastatic, has the CLDN18.2 marker in a tumor sample and has not previously been treated with chemotherapy. Metastatic means the cancer has spread to other parts of the body. People cannot take part are if they have recently had radiotherapy and have not recovered, need to take medicines to suppress their immune system, have history of nervous system metastases from their pancreatic cancer, or they have other active cancers that need treatment. People who have a specific heart condition or infections also cannot take part.
This study will be in 2 parts. Part 1 is called the Safety Lead-in Phase. Groups of people will receive 1 of 2 different doses of zolbetuximab: a lower dose or a higher dose, both together with chemotherapy. A medical expert panel will check the results and decide the dose to use in Part 2.
Part 2 is called the Randomization Phase. People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself. The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself. In both parts of the study, zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein. This is called an infusion. Each treatment cycle is 4 weeks (28 days) long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle. People will visit the clinic on certain days during their treatment. The study doctors will check for any medical problems from zolbetuximab. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken before treatment if a previous sample is not available. People will have the option of giving a tumor sample after treatment has finished. People will visit the clinic after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
Astellas is terminating the zolbetuximab pancreatic development program from Dec 2025 (following the final OS analysis in Oct 2025). Active subjects may remain on treatment if the investigator determines they are receiving benefit from it. The Survival follow-up period is no longer required.
Read the detailed description
This study will have a safety lead in phase and a randomization phase.
- Being tested
- zolbetuximab, nab-paclitaxel, gemcitabine
- Keywords
- metastatic pancreatic cancer, IMAB362, nab-paclitaxel, gemcitabine, zolbetuximab, metastatic pancreatic adenocarcinoma, pancreatic cancer, CLDN 18.2
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolbetuximabDrug
Also called IMAB362
Administered as an intravenous infusion.
nab-paclitaxelDrug
Administered as an intravenous infusion
gemcitabineDrug
Administered as an intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| zolbetuximab +nab-paclitaxel + gemcitabine | Experimental | Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first. Receives: Drug: zolbetuximab; Drug: nab-paclitaxel; Drug: gemcitabine |
| nab-paclitaxel + gemcitabine | Active comparator | Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first. Receives: Drug: nab-paclitaxel; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT) - (safety lead in)
Incidence of dose limiting toxicities.
Measured: Up to 28 days
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Up to 79 months
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months)
Safety assessed by incidence of serious adverse events (SAE)
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Measured: From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months)
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Measured: From first dose up to 30 days after last dose (Up to 80 months)
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Measured: From first dose up to 30 days after last dose (Up to 80 months)
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Measured: From first dose up to 30 days after last dose (Up to 80 months)
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
Measured: From first dose up to 30 days after last dose (Up to 80 months)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Measured: From first dose up to 30 days after last dose (Up to 80 months)
Secondary outcomes (32)
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of radiological progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by investigator evaluation or death from any cause, whichever is earliest.
Measured: Up to 79 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Measured: Up to 79 months
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Measured: Up to 79 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have best overall response of stable disease, complete response (CR) or partial response (PR) as assessed by investigator evaluation per RECIST 1.1
Measured: Up to 79 months
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earliest.
Measured: Up to 79 months
Change in CA (Cancer Antigen) 19-9
Change from baseline in serum CA19-9 will be assessed.
Measured: Up to 79 months
PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)
Ctrough will be derived from the PK serum samples collected.
Measured: Up to 79 months
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
AUClast will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of Nab-P: Maximum Concentration (Cmax)
Cmax will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of Nab-P: Time of Maximum Concentration (Tmax)
Tmax will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of Nab-P: Terminal Elimination Half-life (T1/2)
T1/2 will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of Nab-P: Clearance (CL)
CL will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)
Vz will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
AUClast will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Maximum Concentration (Cmax)
Cmax will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Time of Maximum Concentration (Tmax)
Tmax will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Terminal Elimination Half-life (T1/2)
T1/2 will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Clearance (CL)
CL will be derived from the PK plasma samples collected.
Measured: Up to 30 days
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)
Vz will be derived from the PK plasma samples collected.
Measured: Up to 30 days
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 79 months
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 79 months
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.
Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Measured: Up to 79 months
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale
The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
Measured: Up to 79 months
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Measured: Up to 79 months
Time to Improvement of pancreatic pain as measured by Quality-of-Life Questionnaire - Core Questionnaire (QLQ-C30)
The QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 79 months
Time to worsening of global health status (GHS)/quality of life (QoL) as measured by QLQ-C30
The QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 79 months
Time to Improvement of pancreatic pain as measured by Quality of Life Questionnaire - Pancreatic Cancer Module 26 (QLQ-PAN26)
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 79 months
Time to worsening of GHS/QoL as measured by QLQ-PAN26
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 79 months
Time to Improvement of pancreatic pain as measured by PGIS
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Measured: Up to 79 months
Time to worsening of GHS/QoL as measured by PGIS
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Measured: Up to 79 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start15 Mar 2019
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816163
- Sponsor's protocol ID
- 8951-CL-5201
- Other IDs
- 2018-002551-15, CTR20220914, 2024-510985-17-00, 2018
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2019
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
- Expanded access
- Available