ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy
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|ClinicalTrials.gov Identifier: NCT02609958|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 29, 2018
This is a single arm, multicentre, Phase 2 study to assess efficacy and safety of ASLAN001 in patients with advanced or metastatic cholangiocarcinoma who progressed on at least 1 line of systemic therapy.
25 evaluable patients will be enrolled in the study. After evaluation of initial response in the first 10 evaluable patients, Sponsor will make a decision on recruitment of an additional 15 evaluable patients. If no response is observed, the study will stop.
The primary objective is to assess efficacy of varlitinib (also known as ASLAN001) as measured by ORR (based on RECIST v1.1). The secondary objectives are to (1) evaluate the efficacy of varlitinib, as measured by DoR, PFS, OS and DCR, (2) assess ORR, DoR, PFS, DCR and OS by tumor EGFR/HER2 status, (3) assess safety and tolerability of ASLAN001 monotherapy. Exploratory objectives are to explore possible relationships between response to ASLAN001 and the protein expression levels and gene mutational status of the proteins and genes via IHC and PCR/Sequencing.
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: Varlitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2A, Single Arm, Multicentre, Study of ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy|
|Actual Study Start Date :||November 16, 2015|
|Actual Primary Completion Date :||July 7, 2017|
|Actual Study Completion Date :||October 11, 2017|
Experimental: Treatment Arm A
Varlitinib (ASLAN001) tablets
varlitinib tablets with:
- Objective Response Rate (ORR) [ Time Frame: Through study duration, estimated 3 years ]Defined as the proportion of patients with a response of PR or CR, as defined by RECIST v1.1 criteria. Data obtained up until disease progression, or last evaluable assessment in the absence of disease progression, will be included in the assessment of ORR.
- Progression Free Survival (PFS) [ Time Frame: Through study duration, estimated 3 years ]PFS is defined as the time from start of treatment until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from study therapy or receives another antitumour therapy prior to disease progression.
- Disease Control Rate (DCR) [ Time Frame: Through study duration, estimated 3 years ]Defined as proportion of patients with a best response of stable disease or better as defined by RECIST v1.1 criteria. Note, a minimum interval of 6 weeks (±5 days) from first dose is required for a patient to be attributed a best response of stable disease. Data obtained up until disease progression, or last evaluable assessment in the absence of disease progression, will be included in the assessment of DCR.
- Duration of Response (DoR) [ Time Frame: Through study duration, estimated 3 years ]
Defined as the time from the date of first documented response until the date of documented disease progression or death in the absence of disease progression, the end of response should coincide with the date of disease progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.
If a patient does not progress following a response, then their DoR will use the PFS censoring time.
- Overall Survival (OS) [ Time Frame: Through study duration, estimated 3 years ]Defined as the time from the date of start of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
- Safety for all advanced or metastatic Cholangiocarcinoma (CCA) subjects (Physical examination, vital signs, weight, ECG parameter, clinical laboratory tests and Adverse Events) [ Time Frame: Through study duration, estimated 3 years ]Patient safety will be evaluated based on physical examination, vital signs (blood pressure [systolic and diastolic], resting pulse, respiratory rate, weight and body temperature), ECG parameters, clinical laboratory tests (hematology, clinical chemistry, coagulation and urinalysis) and AEs.
- Possible relationship of protein expression level and gene mutational status determined from archival material or biopsy tissue samples with response to ASLAN001. [ Time Frame: Through study duration, estimated 3 years ]Possible relationship of protein expression level and gene mutational status determined from archival material or biopsy tissue samples with response to ASLAN001, using IHC, PCR/Sequencing and if additional material is available, IHC staining methods.
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): NCT02609958
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Please contact us for more information||ASLAN Pharmaceuticals Pte Ltd|