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

October 16, 2017 updated by: ASLAN Pharmaceuticals

Randomized Phase 2A/2B Study to Compare the Efficacy and Safety of ASLAN001 + Capecitabine to Lapatinib + Capecitabine in Patients With HER 2-Positive MBC That Has Failed on Prior Trastuzumab Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm A
ASLAN001 + Capecitabine
Drug: ASLAN001
ASLAN001 400mg BID
Drug: Capecitabine
Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle
Other Names:
  • Xeloda
Active Comparator: Treatment Arm B
Lapatinib + Capecitabine
Drug: Capecitabine
Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle
Other Names:
  • Xeloda
Drug: Lapatinib
Lapatinib 1250mg QD
Other Names:
  • Tykerb

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety for all metastatic breast cancer (MBC) subjects (Physical examination, body weight, vital signs, ECG parameter, hematology, clinical laboratory tests and Adverse Events)
Time Frame: estimated 2 years
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)
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
Time Frame: Week 12
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)
Time Frame: 2 years
Composite outcome measures
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ASLAN Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASLAN001-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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