NCT02338245

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
7 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2016

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

January 6, 2015

Last Update Submit

October 16, 2017

Conditions

Metastatic Breast Cancer

Outcome Measures

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

    Week 12

Secondary Outcomes (3)

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

    estimated 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

    Week 12

  • 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)

    2 years

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

ASLAN001 + Capecitabine

Drug: ASLAN001Drug: Capecitabine

Treatment Arm B

ACTIVE COMPARATOR

Lapatinib + Capecitabine

Drug: LapatinibDrug: Capecitabine

Interventions

ASLAN001DRUG

ASLAN001 400mg BID

Treatment Arm A
LapatinibDRUG

Lapatinib 1250mg QD

Also known as: Tykerb
Treatment Arm B
CapecitabineDRUG

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

Also known as: Xeloda
Treatment Arm ATreatment Arm B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Australia

Western Australia, 6000, Australia

Location

Hong Kong

Hong Kong, Hong Kong

Location

New Zealand

Christchurch, 8140, New Zealand

Location

New Zealand

Tauranga, 3143, New Zealand

Location

Philippines

Bacolod City, Philippines

Location

Philippines

Dasmariñas, Philippines

Location

Singapore

Singapore, 119074, Singapore

Location

Singapore

Singapore, 169610, Singapore

Location

South Korea

Seoul, 110-744, South Korea

Location

South Korea

Seoul, 135-710, South Korea

Location

South Korea

Seoul, 137-701, South Korea

Location

South Korea

Seoul, 138-736, South Korea

Location

Taiwan

Linkou District, Taoyuan, 333, Taiwan

Location

Taiwan

Kaohsiung City, 833, Taiwan

Location

Taiwan

Taichung, 40447, Taiwan

Location

Taiwan

Taipei, 10449, Taiwan

Location

Taiwan

Taipei, 10507, Taiwan

Location

Taiwan

Taipei, 112, Taiwan

Location

Taiwan

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LapatinibCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 14, 2015

Study Start

December 29, 2014

Primary Completion

May 19, 2016

Study Completion

August 25, 2016

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

KR(4)TW(7)SG(2)NZ(2)HK(1)PH(2)AU(1)