Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02338245
• Date of registration: 06/01/2015
• Prospective Registration: No
• Primary sponsor: Aslan Pharmaceuticals
• Public title: Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab
• Scientific title: Randomized Phase 2A/2B Study to Compare the Efficacy and Safety of ASLAN001 + Capecitabine to Lapatinib + Capecitabine in Patients With HER 2-Positive MBC That Has Failed on Prior Trastuzumab Therapy
• Date of first enrolment: December 29, 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02338245
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Hong Kong, Korea, Republic of, New Zealand, Philippines, Singapore, Taiwan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with documented histological confirmation of breast cancer with HER 2
overexpression or gene amplification prior to study entry.

- 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.

- Presence of at least one radiographically measurable disease (bone metastases and
ascites are not considered measurable lesions).

- Patients of the respective country's legal age or older at the time of written
informed consent.

- Patients with acceptable organ and hematological function

Exclusion Criteria:

- Patients with radiation treatment or major surgical procedures within 21 days prior to
study entry.

- Patients with malabsorption syndrome, diseases significantly affecting
gastrointestinal function, resection of the stomach or small bowel, or difficulty in
swallowing and retaining oral medications.

- 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.

- 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).

- Patients with symptomatic central nervous system metastasis and/or on systemic
steroids or anticonvulsants within 3 months before the first dose of randomized
therapy.

- Patients who are pregnant or breast-feeding.

- Patients who were previously treated with ASLAN001 and/or with lapatinib.

- Patients who have received more than 2 lines of any therapies in metastatic stage.

- 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.

- Patients with unresolved or unstable serious toxicity from prior administration of
another investigational drug and/or prior cancer treatment.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Capecitabine

Drug: ASLAN001

Drug: Lapatinib

Primary Outcome(s)

To compare the efficacy of ASLAN001 in combination with capecitabine, to lapatinib in combination with capecitabine in the percentage change from baseline tumor size at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

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) [Time Frame: 2 years]

To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by PFS and tumor volume [Time Frame: Week 12]

Safety for all metastatic breast cancer (MBC) subjects (Physical examination, body weight, vital signs, ECG parameter, hematology, clinical laboratory tests and Adverse Events) [Time Frame: estimated 2 years]

Secondary ID(s)

ASLAN001-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors