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

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ClinicalTrials.gov Identifier: NCT02338245
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Aslan Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: ASLAN001 Drug: Lapatinib Drug: Capecitabine Phase 2

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 29, 2014
Actual Primary Completion Date : May 19, 2016
Actual Study Completion Date : August 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Xeloda

Active Comparator: Treatment Arm B
Lapatinib + Capecitabine
Drug: Lapatinib
Lapatinib 1250mg QD
Other Name: Tykerb

Drug: Capecitabine
Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle
Other Name: Xeloda




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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)

  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) [ Time Frame: 2 years ]
    Composite outcome measures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338245


Locations
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Australia
Australia
Western Australia, Australia, 6000
Hong Kong
Hong Kong
Hong Kong, Hong Kong
Korea, Republic of
South Korea
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
New Zealand
New Zealand
Christchurch, New Zealand, 8140
New Zealand
Tauranga, New Zealand, 3143
Philippines
Philippines
Bacolod City, Philippines
Philippines
Dasmarinas, Philippines
Singapore
Singapore
Singapore, Singapore, 119074
Singapore
Singapore, Singapore, 169610
Taiwan
Taiwan
Linkou, Taoyuan, Taiwan, 333
Taiwan
KaohSiung, Taiwan, 833
Taiwan
Taichung, Taiwan, 40447
Taiwan
Taipei, Taiwan, 10449
Taiwan
Taipei, Taiwan, 10507
Taiwan
Taipei, Taiwan, 112
Taiwan
Taipei, Taiwan, 114
Sponsors and Collaborators
Aslan Pharmaceuticals

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Responsible Party: Aslan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02338245     History of Changes
Other Study ID Numbers: ASLAN001-003
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Capecitabine
Trastuzumab
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors