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

Sponsor
ASLAN Pharmaceuticals
Study ID
NCT02338245
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASLAN001 — DRUG
    ASLAN001 400mg BID
  • Lapatinib — DRUG
    Lapatinib 1250mg QD
  • Capecitabine — DRUG
    Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle

Study Details

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.

Key Dates

Start date
Dec 29, 2014
Status verified
Oct 2017
Primary completion
May 19, 2016
Completion
Aug 25, 2016

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    ASLAN001 + Capecitabine
  • Active Comparator: Treatment Arm B
    Lapatinib + Capecitabine

Primary Outcome Measure

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 ]

Related Studies