Clinical Trials List
Protocol NumberASLAN001-003
2014-12-01 - 2018-06-30
Phase II
Terminated6
Study ended1
ICD-10C79.81
Secondary malignant neoplasm of breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9198.81
Secondary malignant neoplasm of breast
A Randomized Phase 2A/2B, Multicenter Study to Compare the Efficacy and Safety of ASLAN001 in Combination with Capecitabine to Lapatinib in Combination with Capecitabine in Patients with HER-2-Positive Metastatic Breast Cancer that has Failed on Prior Trastuzumab Therapy
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Wen-Chi Shen Division of Hematology & Oncology
- 沈士哲 Division of General Surgery
- Shin-Cheh Chen Division of General Surgery
- 周旭桓 Division of General Surgery
- Yung-Chang Lin Division of Hematology & Oncology
- Hsien-Kun Chang Division of Hematology & Oncology
- Chi-Chang Yu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳彥仰 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
- Meng-Jer Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 金光亮 Division of General Surgery
- Chun-Yu Liu Division of Hematology & Oncology
- 王國鐘 Division of General Surgery
- Ta-Chung Chao Division of Hematology & Oncology
- 邱仁輝 Division of General Surgery
- 賴亦貞 Division of Radiology
- Yi-Fang Tsai Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Liang-Chih Liu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
The Actual Total Number of Participants Enrolled
2 Study ended
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Breast Cancer
Objectives
Primary Objective:
To compare the efficacy of ASLAN001 in combination with capecitabine, to lapatinib in
combination with capecitabine:
In Phase 2A: the primary endpoint is the percentage change from baseline in tumor size at Week 12.
In Phase 2B: the primary endpoint is progression-free survival (PFS).
Secondary Objectives:
To assess the safety and tolerability of ASLAN001 in combination with capecitabine.
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by PFS and tumor volume – Phase 2A only.
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by the Objective
Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS)
– both Phase 2A and 2B.
Test Drug
ASLAN001
Active Ingredient
Dosage Form
Dosage
100
Endpoints
Percentage change from baseline in tumor size at Week 12: defined as the percentage change from baseline in the sum of longest diameters of target lesions.
PFS: defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from randomized therapy or receives another antitumor therapy prior to disease progression. Disease progression is defined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Percentage change from baseline in tumor volume at Week 12: defined as the percentage change from baseline in the sum of volumes of target lesions (enhanced RECIST Version 1.1).
ORR: the proportion of patients with at least 1 visit response of complete response (CR) or partial response (PR), as defined by RECIST Version 1.1.
DoR: defined as the time from the date of first documented response until the date of documented disease progression or death in the absence of disease progression.
OS: defined as the time from the date of randomization until death due to any cause.
PFS: defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from randomized therapy or receives another antitumor therapy prior to disease progression. Disease progression is defined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Percentage change from baseline in tumor volume at Week 12: defined as the percentage change from baseline in the sum of volumes of target lesions (enhanced RECIST Version 1.1).
ORR: the proportion of patients with at least 1 visit response of complete response (CR) or partial response (PR), as defined by RECIST Version 1.1.
DoR: defined as the time from the date of first documented response until the date of documented disease progression or death in the absence of disease progression.
OS: defined as the time from the date of randomization until death due to any cause.
Inclution Criteria
1. Patients with documented histological confirmation of breast cancer with HER-2
overexpression or gene amplification (immunohistochemistry 3+ or immunohistochemistry 2+ with fluorescent / chromogenic / silver in situ
hybridization +) prior to study entry.
2. Patients with HER-2-positive metastatic breast cancer that have failed on prior
first-line treatment with trastuzumab or who have progressed within 1 year of treatment with trastuzumab in adjuvant setting.
3. Inclusion criteria for phase 2A only: Presence of at least one radiographically
measurable disease (bone metastases and ascites are not considered measurable
lesions).
4. Patients of the respective country’s legal age or older at the time of written informed
consent.
5. Patients of childbearing potential to use adequate contraception prior to, during the
study, and 12 weeks after the last dose of randomized therapy.
6. Patients able to understand and willing to sign the informed consent form.
7. Patients with Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
8. Patients with acceptable organ and hematological function:
Hematological function:
o Absolute neutrophil count ≥1.5 × 109/L.
o Platelet count ≥100 × 109/L.
o Hemoglobin ≥9 g/L.
Renal functions:
o Serum creatinine ≤1.5 × upper limit of normal (ULN).
Hepatic function:
o Total bilirubin ≤1.5 × ULN.
o Aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN
(≤5 × ULN if liver metastases are present).
9. Patient with left ventricular ejection fraction (LVEF) within institutional limits of
normal during screening. If the LVEF is not within the institutional limits, the subject will be included only if the results are assessed as clinically not significant by the investigator and/or cardiologist.
overexpression or gene amplification (immunohistochemistry 3+ or immunohistochemistry 2+ with fluorescent / chromogenic / silver in situ
hybridization +) prior to study entry.
2. Patients with HER-2-positive metastatic breast cancer that have failed on prior
first-line treatment with trastuzumab or who have progressed within 1 year of treatment with trastuzumab in adjuvant setting.
3. Inclusion criteria for phase 2A only: Presence of at least one radiographically
measurable disease (bone metastases and ascites are not considered measurable
lesions).
4. Patients of the respective country’s legal age or older at the time of written informed
consent.
5. Patients of childbearing potential to use adequate contraception prior to, during the
study, and 12 weeks after the last dose of randomized therapy.
6. Patients able to understand and willing to sign the informed consent form.
7. Patients with Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
8. Patients with acceptable organ and hematological function:
Hematological function:
o Absolute neutrophil count ≥1.5 × 109/L.
o Platelet count ≥100 × 109/L.
o Hemoglobin ≥9 g/L.
Renal functions:
o Serum creatinine ≤1.5 × upper limit of normal (ULN).
Hepatic function:
o Total bilirubin ≤1.5 × ULN.
o Aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN
(≤5 × ULN if liver metastases are present).
9. Patient with left ventricular ejection fraction (LVEF) within institutional limits of
normal during screening. If the LVEF is not within the institutional limits, the subject will be included only if the results are assessed as clinically not significant by the investigator and/or cardiologist.
Exclusion Criteria
1. Patients with radiation treatment or major surgical procedures within 21 days prior
to study entry.
2. Patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications.
3. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes, hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
4. Patients with any history of other malignancy unless in remission for more than 1 year. (Nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary).
5. Patients with symptomatic central nervous system metastasis and/or on systemic steroids or anticonvulsants within 3 months before the first dose of randomized therapy.
6. Patients who are pregnant or breast-feeding.
7. Patients who were previously treated with ASLAN001 and/or with lapatinib.
8. Patients who have received more than 2 lines of any therapies in metastatic stage.
9. Patients who have received any investigational drug (or have used an investigational
device) within 21 days or received any antineoplastic monoclonal antibodies within a period of 5 half-lives before receiving the first dose of randomized therapy.
10. Patients with unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment.
11. Patient with known active infection on hepatitis B and hepatitis C and dihydropyrimidine dehydrogenase (DPD) deficiency.
to study entry.
2. Patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications.
3. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes, hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
4. Patients with any history of other malignancy unless in remission for more than 1 year. (Nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary).
5. Patients with symptomatic central nervous system metastasis and/or on systemic steroids or anticonvulsants within 3 months before the first dose of randomized therapy.
6. Patients who are pregnant or breast-feeding.
7. Patients who were previously treated with ASLAN001 and/or with lapatinib.
8. Patients who have received more than 2 lines of any therapies in metastatic stage.
9. Patients who have received any investigational drug (or have used an investigational
device) within 21 days or received any antineoplastic monoclonal antibodies within a period of 5 half-lives before receiving the first dose of randomized therapy.
10. Patients with unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment.
11. Patient with known active infection on hepatitis B and hepatitis C and dihydropyrimidine dehydrogenase (DPD) deficiency.
The Estimated Number of Participants
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Taiwan
140 participants
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Global
204 participants
