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

• Status: Completed
• Trial end date: 2016-08-25
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aslan Pharmaceuticals
• Treatments: Capecitabine; Lapatinib; Trastuzumab

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.