Clinical Trials List
Protocol NumberI3Y-MC-JPCJ
NCT Number(ClinicalTrials.gov Identfier)NCT02981342
Completed
2017-03-23 - 2019-03-31
Phase II
Terminated3
ICD-10C25
Malignant neoplasm of pancreas
ICD-9157.3
Malignant neoplasm of pancreatic duct
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yi-Ping Hung Division of Hematology & Oncology
- Yee Chao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
9 Terminated
Audit
CRO
Co-Principal Investigator
- Li-Tzong Chen Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Nai-Jung Chiang Division of Hematology & Oncology
- 趙盈瑞 Division of General Surgery
- 姜乃榕 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- 林育麟 Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- - - Division of General Internal Medicine
- Chiun Hsu Division of Hematology & Oncology
- JHE-CYUAN GUO Division of Hematology & Oncology
- 陳國興 Division of Hematology & Oncology
- Ann-Lii Cheng Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- 梁逸歆 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Metastatic Pancreatic Ductal Adenocarcinoma
Objectives
To evaluate disease control rate of the abemaciclib treatment arms versus the standard-of-care arm
(gemcitabine or capecitabine)
Test Drug
Abemaciclib（LY2835219）
Active Ingredient
LY28353219
Dosage Form
Capsule
Dosage
50
Endpoints
Disease control rate is the percentage of patients with a best overall response of stable disease, complete response, or partial response according to RECIST 1.1
Inclution Criteria
Inclusion Criteria
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] have cytologically or histologically confirmed diagnosis of ductal
adenocarcinoma of the pancreas.
[2] have metastatic disease with documented disease progression following
previous treatment with at least one, but no more than 2 prior therapies, with
one of the prior therapies having been either gemcitabine-based or
fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for
localized resectable or unresectable PDAC each count as a line of therapy if
multiagent chemotherapy regimens were administered (and neoadjuvant
regimen was different than adjuvant regimen) and if the patient progressed
with metastatic disease while taking or within 6 months of completion of
(neo)adjuvant therapy.
[3] have the presence of measurable disease as defined by Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Eisenhauer et al. 2009).
[4] have a performance status (PS) of 0 to 1 on the ECOG scale (Oken et al.
1982).
[5] is a patient for whom treatment with monotherapy chemotherapy such as
gemcitabine or capecitabine is a reasonable choice.
[6] have discontinued all previous treatments for cancer (including cytotoxic
chemotherapy, molecularly targeted therapy, radiotherapy, immunotherapy,
and investigational therapy) for at least 14 days prior to receiving the initial
dose of study treatment, and recovered from the acute effects of therapy
(treatment-related toxicity resolved to baseline) except for residual alopecia or
peripheral neuropathy
[7] have adequate organ function, as defined below:
[8] are at least 18 years old at the time of screening or of an age acceptable
according to local regulations, whichever is older.
[9] men must be sterile or agree to use an effective method of contraception or a
highly effective method of contraception during the study and for at least
6 months following the last dose of study drug.
Refer to Appendix 1 for definitions of effective method of contraception and
highly effective method of contraception.
[10] women of child-bearing potential must:
a. have a negative serum pregnancy test within 7 days prior to study
treatment initiation, and
b. agree to use a highly effective method of contraception during the study
and for at least 6 months following the last dose of study drug
[11] have given written informed consent prior to any study-specific procedures.
[12] are able to swallow capsules and tablets.
[13] are reliable and willing to make themselves available for the duration of the
study and are willing to follow study procedures.
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] have cytologically or histologically confirmed diagnosis of ductal
adenocarcinoma of the pancreas.
[2] have metastatic disease with documented disease progression following
previous treatment with at least one, but no more than 2 prior therapies, with
one of the prior therapies having been either gemcitabine-based or
fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for
localized resectable or unresectable PDAC each count as a line of therapy if
multiagent chemotherapy regimens were administered (and neoadjuvant
regimen was different than adjuvant regimen) and if the patient progressed
with metastatic disease while taking or within 6 months of completion of
(neo)adjuvant therapy.
[3] have the presence of measurable disease as defined by Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Eisenhauer et al. 2009).
[4] have a performance status (PS) of 0 to 1 on the ECOG scale (Oken et al.
1982).
[5] is a patient for whom treatment with monotherapy chemotherapy such as
gemcitabine or capecitabine is a reasonable choice.
[6] have discontinued all previous treatments for cancer (including cytotoxic
chemotherapy, molecularly targeted therapy, radiotherapy, immunotherapy,
and investigational therapy) for at least 14 days prior to receiving the initial
dose of study treatment, and recovered from the acute effects of therapy
(treatment-related toxicity resolved to baseline) except for residual alopecia or
peripheral neuropathy
[7] have adequate organ function, as defined below:
[8] are at least 18 years old at the time of screening or of an age acceptable
according to local regulations, whichever is older.
[9] men must be sterile or agree to use an effective method of contraception or a
highly effective method of contraception during the study and for at least
6 months following the last dose of study drug.
Refer to Appendix 1 for definitions of effective method of contraception and
highly effective method of contraception.
[10] women of child-bearing potential must:
a. have a negative serum pregnancy test within 7 days prior to study
treatment initiation, and
b. agree to use a highly effective method of contraception during the study
and for at least 6 months following the last dose of study drug
[11] have given written informed consent prior to any study-specific procedures.
[12] are able to swallow capsules and tablets.
[13] are reliable and willing to make themselves available for the duration of the
study and are willing to follow study procedures.
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria:
[14] have a serious concomitant systemic disorder or preexisting condition (for
example, active infection including human immunodeficiency virus, history of
major surgical resection involving the stomach or small bowel, or preexisting
Crohn’s disease or ulcerative colitis) that, in the opinion of the investigator,
would compromise the patient’s safety or ability to adhere to the protocol.
[15] have severe cardiac disease:
Myocardial infarction within 6 months prior to study screening, unstable angina
pectoris, New York Heart Association Class III/IV congestive heart failure, or
uncontrolled hypertension.
Documented major electrocardiogram (ECG) abnormalities, at the investigator’s
discretion (for example, symptomatic or sustained atrial or ventricular
arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks,
ventricular hypertrophy, or recent myocardial infarction), not responding to
medical treatments or not clinically stable for at least 6 months prior to study
screening.
Major cardiac abnormalities documented by echocardiography (ECHO) with
Doppler that are not clinically stable for at least 6 months prior to study screening
(for example, severe heart valve function defect and/or left ventricular ejection
fraction [LVEF] <50%, evaluation based on the institutional lower limit of
normal). For additional details, refer to Echocardiography Protocol (Appendix 6).
[16] Predisposing conditions that are consistent with development of aneurysms of
the ascending aorta or aortic stress (for example, family history of aneurysms,
Marfan Syndrome, bicuspid aortic valve, or evidence of damage to the large
vessels of the heart documented by Computed Tomography [CT] scan or
magnetic resonance imaging [MRI] with contrast).
[17] have insulin-dependent diabetes mellitus. Patients with type 2 diabetes
mellitus are eligible if adequate control of blood glucose level is obtained by
oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.
[18] have symptomatic central nervous system metastasis. Screening of
asymptomatic patients is not required for enrollment.
[19] have a history of any other cancer (except nonmelanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission with no therapy
for a minimum of 2 years.
[20] have had major surgery within 7 days prior to initiation of study drug to allow for
postoperative healing of the surgical wound and site(s).
[21] are currently enrolled in a clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study. If a patient is currently enrolled in a clinical trial
involving nonapproved use of a device, then agreement with the investigator
and Lilly clinical research physician (CRP) is required to establish eligibility.
[22] have received treatment with a drug that has not received regulatory approval
for any indication within 14 days prior to receiving the initial dose of study
treatment.
[23] have previously received treatment with any CDK4 and 6 inhibitor, TGF-
inhibitor, or PI3K and/or mTOR inhibitor or have a known hypersensitivity to
any component of the investigational products in this study.
[24] have a known hypersensitivity to gemcitabine or capecitabine.
[25] are pregnant or breastfeeding
Patients will be excluded from the study if they meet any of the following criteria:
[14] have a serious concomitant systemic disorder or preexisting condition (for
example, active infection including human immunodeficiency virus, history of
major surgical resection involving the stomach or small bowel, or preexisting
Crohn’s disease or ulcerative colitis) that, in the opinion of the investigator,
would compromise the patient’s safety or ability to adhere to the protocol.
[15] have severe cardiac disease:
Myocardial infarction within 6 months prior to study screening, unstable angina
pectoris, New York Heart Association Class III/IV congestive heart failure, or
uncontrolled hypertension.
Documented major electrocardiogram (ECG) abnormalities, at the investigator’s
discretion (for example, symptomatic or sustained atrial or ventricular
arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks,
ventricular hypertrophy, or recent myocardial infarction), not responding to
medical treatments or not clinically stable for at least 6 months prior to study
screening.
Major cardiac abnormalities documented by echocardiography (ECHO) with
Doppler that are not clinically stable for at least 6 months prior to study screening
(for example, severe heart valve function defect and/or left ventricular ejection
fraction [LVEF] <50%, evaluation based on the institutional lower limit of
normal). For additional details, refer to Echocardiography Protocol (Appendix 6).
[16] Predisposing conditions that are consistent with development of aneurysms of
the ascending aorta or aortic stress (for example, family history of aneurysms,
Marfan Syndrome, bicuspid aortic valve, or evidence of damage to the large
vessels of the heart documented by Computed Tomography [CT] scan or
magnetic resonance imaging [MRI] with contrast).
[17] have insulin-dependent diabetes mellitus. Patients with type 2 diabetes
mellitus are eligible if adequate control of blood glucose level is obtained by
oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.
[18] have symptomatic central nervous system metastasis. Screening of
asymptomatic patients is not required for enrollment.
[19] have a history of any other cancer (except nonmelanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission with no therapy
for a minimum of 2 years.
[20] have had major surgery within 7 days prior to initiation of study drug to allow for
postoperative healing of the surgical wound and site(s).
[21] are currently enrolled in a clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study. If a patient is currently enrolled in a clinical trial
involving nonapproved use of a device, then agreement with the investigator
and Lilly clinical research physician (CRP) is required to establish eligibility.
[22] have received treatment with a drug that has not received regulatory approval
for any indication within 14 days prior to receiving the initial dose of study
treatment.
[23] have previously received treatment with any CDK4 and 6 inhibitor, TGF-
inhibitor, or PI3K and/or mTOR inhibitor or have a known hypersensitivity to
any component of the investigational products in this study.
[24] have a known hypersensitivity to gemcitabine or capecitabine.
[25] are pregnant or breastfeeding
The Estimated Number of Participants
-
Taiwan
25 participants
-
Global
250 participants
