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CompletedNCT02338245Updated Oct 17, 2017

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

A Phase 2 interventional study of ASLAN001 and Lapatinib in Metastatic Breast Cancer, sponsored by ASLAN Pharmaceuticals. Completed at 19 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-17.

Sponsored by ASLAN Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the detailed description

Phase 2A Design:

The Phase 2A part is an open-label, randomized, parallel group study using tumor size as its primary efficacy endpoint. Approximately 44 eligible patients will be randomized in a 1:1 ratio to receive either ASLAN001 400 mg orally twice daily (BID) or lapatinib 1250 mg orally once daily (QD), both on a background of capecitabine 1000 mg/m2 orally BID for Days 1-14 of a 21-day cycle. Radiological imaging to assess disease status will be performed at baseline and every 6 weeks until disease progression (as assessed by the Investigator). Patients who have not experienced disease progression after 12 weeks may continue to receive randomized therapy and will continue to have radiological scans every 6 weeks until disease progression.

Criteria to Proceed to Phase 2B:

In the absence of any safety or tolerability concerns, continuation to the Phase 2B part of the study will be primarily based on the statistical comparison of the percentage change in tumor size from baseline to Week 12 and a one-sided p-value \<0.1 in favor of the ASLAN001-containing treatment arm would be supportive of continuation to Phase 2B.

Phase 2B Design:

The Phase 2B part of the study will continue to recruit if the pre-specified efficacy criteria are met in the Phase 2A part and if the tolerability of ASLAN001 in combination with capecitabine is considered acceptable.

The Phase 2B part is an open-label, randomized, parallel group study. In this part, approximately 160 patients will be randomized in a 1:1 ratio to receive either ASLAN001 400 mg BID or lapatinib 1250 mg QD, both in combination with capecitabine 1000 mg/m2 BID for Days 1-14 of a 21-day cycle.

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Conditions studied

  • Metastatic Breast Cancer
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In context

Lead sponsor

ASLAN Pharmaceuticals is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Treatment Arm A

    ASLAN001 + Capecitabine

    Drug: ASLAN001 · Drug: Capecitabine

  • Active comparator
    Treatment Arm B

    Lapatinib + Capecitabine

    Drug: Lapatinib · Drug: Capecitabine

Interventions

  • DrugASLAN001

    ASLAN001 400mg BID

  • DrugLapatinib

    Lapatinib 1250mg QD

    Also known as: Tykerb

  • DrugCapecitabine

    Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle

    Also known as: Xeloda

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Safety for all metastatic breast cancer (MBC) subjects (Physical examination, body weight, vital signs, ECG parameter, hematology, clinical laboratory tests and Adverse Events)

    Physical exam, body weight, vital signs (Blood pressure, respiratory rate and body temperateure), ECG parameter, hematology, clinical laboratory tests (clinical chemistry, coagulation and urinalysis) and Adverse Events (AEs)/ Serious Adverse Events (SAEs)

    Time frame: estimated 2 years

  2. 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

  3. 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)

    Composite outcome measures

    Time frame: 2 years

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Study locations

19 sites
  • Australia
    Western Australia, 6000, Australia
  • Hong Kong
    Hong Kong, Hong Kong
  • South Korea
    Seoul, 110-744, Korea, Republic of
  • South Korea
    Seoul, 135-710, Korea, Republic of
  • South Korea
    Seoul, 137-701, Korea, Republic of
  • South Korea
    Seoul, 138-736, Korea, Republic of
  • New Zealand
    Christchurch, 8140, New Zealand
  • New Zealand
    Tauranga, 3143, New Zealand
  • Philippines
    Bacolod City, Philippines
  • Philippines
    Dasmarinas, Philippines
  • Singapore
    Singapore, 119074, Singapore
  • Singapore
    Singapore, 169610, Singapore
  • Taiwan
    Linkou, Taoyuan 333, Taiwan
  • Taiwan
    KaohSiung, 833, Taiwan
  • Taiwan
    Taichung, 40447, Taiwan
  • Taiwan
    Taipei, 10449, Taiwan
  • Taiwan
    Taipei, 10507, Taiwan
  • Taiwan
    Taipei, 112, Taiwan
  • Taiwan
    Taipei, 114, Taiwan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02338245
Lead sponsor
ASLAN Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
Dec 29, 2014
Primary completion
May 19, 2016
Completion
Aug 25, 2016
Last update
Oct 17, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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