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

NCT02338245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-10-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

ASLAN001

ASLAN001 400mg BID

DRUG

Lapatinib

Lapatinib 1250mg QD

DRUG

Capecitabine

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

Sponsors & Collaborators

  • ASLAN Pharmaceuticals

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-29
Primary Completion
2016-05-19
Completion
2016-08-25

Countries

  • Australia
  • Hong Kong
  • New Zealand
  • Philippines
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02338245 on ClinicalTrials.gov