Biliary Tract CancerPhase 2/3TreeToppNCT03093870
Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
A Phase 2/3 study testing Varlitinib and Capecitabine in people with Biliary Tract Cancer, run by ASLAN Pharmaceuticals at 21 sites in 11 countries.
Trial summary
This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Varlitinib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 21 sitesin 11 countries
- Study dates
- 4 Jul 2017to 17 Apr 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects will be eligible for the study if they:
- Are of or older than the legal age in the respective countries at the time when written informed consent is obtained
- Have histologically or cytologically confirmed advanced (unresectable) or metastatic biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma (CCA), gallbladder cancer and carcinoma of Ampulla of Vater. This includes clinical diagnosis of biliary tract cancer with histological confirmation of adenocarcinoma.
- Have received and failed one and only one prior line of systemic treatment for advanced or metastatic disease with radiologic evidence of disease progression. This prior line of systemic treatment must also contain gemcitabine
- Have received at least 6 doses of gemcitabine containing treatment in first line (Adjuvant therapy is not regarded as 1st line therapy)
- Have radiographically measurable disease based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as assessed by Independent Central Review (ICR) (For Part 1)
Show all 19Show fewer
- Have no evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below or equal to 1.5 × upper level of normal (ULN)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Are able to understand and willing to sign the informed consent form
- Have adequate organ and hematological function:
- Hematological function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelet count ≥ 100 × 109/L
- Renal functions, as follows:
- Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73m2
- Hepatic function, as follows:
- Albumin ≥ 3 g/dL
- Total bilirubin ≤ 1.5 × ULN
- Aspartate aminotransferase and alanine aminotransferase ≤ 5 × ULN
Who cannot join
- Subjects will be ineligible for the study if they:
- Are currently on or have received anti-cancer therapy within the past 3 weeks before receiving the first dose of study medication
- Are currently on or have received radiation or local treatment within the past 3 weeks for the target lesion(s) before receiving the first dose of study medication
- Have evidence of multiple (≥ 2) peritoneal metastases or ascites at baseline as assessed by ICR (For Part 1). (Ascites which can be attributed by non-malignant causes is not excluded. Minimal ascites, which does not require paracentesis is permitted.)
- Have had major surgical procedures within 14 days prior to first dose of study medication
- Have a known metastatic brain lesion(s), including asymptomatic and well controlled lesion(s)
Show all 19Show fewer
- Have malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications which in the opinion of the Investigator could jeopardize the validity of the study results
- Have 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
- Have any history of other malignancy unless in remission for more than 1 year (non-melanoma skin carcinoma and carcinoma-in-site of uterine cervix treated with curative intent is not exclusionary)
- Are female patients who are pregnant or breast feeding
- Have been previously treated with varlitinib or have been previously treated with capecitabine as first line therapy for advanced or metastatic disease. For patients who have previously received capecitabine as a radiosensitizer or as part of their adjuvant therapy and their disease has relapsed for more than 6 months after their last dose of capecitabine adjuvant therapy, their capecitabine therapy will not be considered as a line of systemic chemotherapy for metastatic/advanced disease, and thus they can participate in the study
- Have received any investigational drug (or have used an investigational device) within the last 14 days before receiving the first dose of study medication
- Have unresolved or unstable serious toxicity (≥ common terminology criteria for adverse events [CTCAE] 4.03 Grade 2), with the exception of anemia, asthenia, and alopecia, from prior administration of another investigational drug and/or prior cancer treatment
- Have a known positive test for human immunodeficiency virus, hepatitis C (treatment naïve or after treatment without sustained virologic response), or hepatitis B infection with hepatitis B virus deoxyribonucleic acid exceeding 2000 IU/mL
- Have a known history of drug addiction within last 1 year which, in the opinion of the Investigator, could increase the risk of non-compliance to investigational product
- Need continuous treatment with proton pump inhibitors during the study period
- Have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or have a history of interstitial lung disease or current interstitial lung disease
- Have any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
- Have a baseline corrected QT interval (Fridericia's formula) (QTcF) > 450 ms or patients with known long QT syndrome; torsade de pointes; symptomatic ventricular tachycardia; an unstable cardiac syndrome in the past 3 months before screening visit; > class 2 New York Heart Association heart failure; or > class 2 angina pectoris; or receiving quinidine, procainamide, disopyramide, amiodarone, dronedarone, arsenic, dofetilide, sotalol, or methadone. Please also see prohibited medication/therapy (Section 5.4.10.1)
Trial locations and contacts
21 sites in 11 countries.
21 sites in 11 countries
United States11 sites
Levine Cancer Institute, Carolinas Healthcare System
Charlotte, North Carolina, 28204
Texas Oncology, P.A.
Dallas, Texas, 12221
Karmanos Cancer Institute/Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27705
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
UT MD Anderson Cancer Center
Houston, Texas, 77030
CCCN
Las Vegas, Nevada, 89169
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Ruttenberg Cancer Center, Mount Sinai Hospital
New York, New York, 10029
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
Washington University School of Medicine
St Louis, Missouri, 63110
Australia1 site
There are 5 sites in different cities in Australia
Camperdown
China1 site
There are 6 sites in different cities in China
Nanjing, Nanjing, 210031
South Korea1 site
There are 15 sites in different cities in South Korea
Seoul
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Varlitinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as Second Line Systemic Therapy
This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine
Read the detailed description
Part 1 of study(Phase 2) is planned to have 120 patients and anticipated completion on July 2019. Recruitment completed.
Part 2 of study(Phase 3) is planned to have 350 patients and anticipated completion on Dec 2022. Not yet recruiting.
- Conditions
- Biliary Tract Cancer
- Being tested
- Varlitinib, Capecitabine, Placebo (for Varlitinib)
- Keywords
- Neoplasms, Biliary Tract Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms
- Medical subject headings
- Biliary Tract Neoplasms, Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VarlitinibDrug
Also called ASLAN001, ARRY-334543, QBT01
Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
CapecitabineDrug
1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Placebo (for Varlitinib)Drug
oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death
| Study group | Role | What they receive |
|---|---|---|
| Varlitinib and Capecitabine | Experimental | Not described Receives: Drug: Varlitinib; Drug: Capecitabine |
| Placebo and Capecitabine | Placebo comparator | Not described Receives: Drug: Capecitabine; Drug: Placebo (for Varlitinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) - Part 1
Part 1: The ORR was defined as the number (%) of subjects with ≥ 1 visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or until last evaluable assessment in the absence of progression, was included in the assessment of ORR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. Best overall RECIST Response (BOR) was calculated based on the overall visit responses from each RECIST assessment, i.e. the best response a subject had following randomization and prior to RECIST progression or the last evaluable assessment in the absence of RECIST progression. Categorization of BOR was based on the RECIST criteria using the following response categories: CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE).
Measured: Data obtained up until progression, or until last evaluable assessment in the absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.
Progression-free Survival (PFS) - Part 1
Part 1: Progression-free survival (PFS) was defined as the time from randomization (or starting treatment for the Safety Lead-in) until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the subject withdrew from randomized therapy or received another antitumor therapy prior to disease progression. Subjects who did not experience disease progression or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. However, if the patient progressed or died after ≥ 2 missed visits (12 weeks ± 5 days maximum), the subject was censored at the time of the latest evaluable RECIST assessment. The PFS time was based on the scan/assessment dates rather than visit dates.
Measured: Time from randomization until date of objective disease progression or death (by any cause in absence of disease progression) regardless of whether subject withdrew from randomized therapy or received another antitumor therapy prior to PD, up to 2 years.
Secondary outcomes (13)
Object Response Rates (ORR) - Safety Lead-In
The ORR rate was defined as the number (%) of subjects with ≥ 1 visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or until last evaluable assessment in the absence of progression, was included in the assessment of ORR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. In all study parts, the primary assessment of ORR was based on the Full Analysis Set (FAS).
Measured: Data obtained up until progression, or until last evaluable assessment in absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.
Overall Survival (OS) - Part 1
Part 1: Overall survival (OS) was defined as the time from the date of randomization until death due to any cause. Any subject not known to have died at the time of the data cut-off was censored based on the last recorded date on which the subject was known to be alive.
Measured: Time from the date of randomization until death due to any cause, up to 2 years
Overall Survival (OS) - Safety Lead-In
Part 1: Overall survival (OS) was defined as the time from the date of randomization until death due to any cause. Any subject not known to have died at the time of the data cut-off was censored based on the last recorded date on which the subject was known to be alive.
Measured: Time from the date of randomization until death due to any cause, up to 2 years
Duration of Response (DoR) - Part 1
Part 1: Duration of response (DoR) was defined as the time from the date of first documented response until the date of documented PD or death in the absence of disease progression. The end of the response should have coincided with the date of disease progression or death from any cause used for the PFS endpoint.
For Part 1, DoR was calculated based on data from the ICR of radiological data.
Measured: Time from the date of first documented response until the date of documented PD or death in the absence of disease progression, up to 2 years
Disease Control Rate DCR - Part 1
Part 1: DCR rate was defined as the number (%) of subjects with ≥ 1 visit response of CR or PR, or with SD for a minimum of 12 weeks (± 5 days) from randomization. Data obtained up until progression, or until last evaluable assessment in the absence of progression, were included in the assessment of DCR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. For all study parts, the primary assessment of DCR was based on the FAS.
For Part 1, DCR was calculated based on data from the ICR
Measured: Number (%) of subjects with ≥ 1 visit response of CR or PR, or with SD for a minimum of 12 weeks (± 5 days) from randomization.
Tumor Size - Part 1
Part 1: The percentage change from baseline in tumor size at Week 12 (%ΔTSWk12) was a secondary endpoint for Part 1 and was used to present waterfall plots of the target lesion data in the Evaluable for Response (EFR) Population
Measured: Week 12
Number of Participants With Clinically Significant Laboratory Tests- Safety Lead-in
Clinical laboratory tests (hematology, clinical chemistry, urinalysis) - Number of Participants with Clinically Significant Laboratory Tests.
Measured: Subject screening visit to 28 days post last study drug administration
Number of Participants With Clinically Significant Laboratory Tests - Part 1
Clinical laboratory tests (hematology, clinical chemistry, urinalysis) - Number of Participants with Clinically Significant Laboratory Tests.
Measured: Subject screening visit to 28 days post last study drug administration
Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Safety Lead-In
Number of participants with clinically significant change in vital signs (blood pressure [diastolic and systolic], heart rate, respiratory rate, body temperature) and physical examination.
Measured: Subject screening visit to 28 days post last study drug administration
Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1
Number of participants with clinically significant change in vital signs (blood pressure [diastolic and systolic], heart rate, respiratory rate, body temperature) and physical examination.
Measured: Subject screening visit to 28 days post last study drug administration
Number of Participants With ECG Parameters of Interest - Safety Lead-In
Number of participants with ECG parameters of interest: Max. on-treatment QTcF Value: >450 to 480 msec, max. on-treatment QTcF Value: >480 to 500 msec, max. on-treatment QTcF Value: >500 msec, max. on-treatment QTcB Value: >450 to 480 msec, max. on-treatment QTcB Value: >480 to 500 msec, max. on-treatment QTcB Value: >500 msec, max. QTcF CFB Value: >30 to 60 msec, max. QTcF CFB Value: >60 msec, max. QTcB CFB Value: >30 to 60 msec, max. QTcB CFB Value: >60 msec.
Measured: Subject screening visit to 28 days post last study drug administration
Number of Participants With ECG Parameters of Interest - Part 1
Number of participants with ECG parameters of interest: Max. on-treatment QTcF Value: <=450 msec, max. on-treatment QTcF Value: >450 to 480 msec, max. on-treatment QTcF Value: >480 to 500 msec, max. on-treatment QTcF Value: >500 msec, max. on-treatment QTcB Value: <=450 msec, max. on-treatment QTcB Value: >450 to 480 msec, max. on-treatment QTcB Value: >480 to 500 msec, max. on-treatment QTcB Value: >500 msec, max. QTcF CFB Value: <=30 msec, max. QTcF CFB Value: >30 to 60 msec, max. QTcF CFB Value: >60 msec, max. QTcB CFB Value: <=30 msec, max. QTcB CFB Value: >30 to 60 msec, max. QTcB CFB Value: >60 msec.
Measured: Subject screening visit to 28 days post last study drug administration
ECOG Performance Status - Part 1
Eastern Cooperative Oncology Group (ECOG) Performance was clinically graded based on the following:
Grade 0 = Normal activity. Fully active, able to carry on all pre-disease performance without restriction.
Grade 1 = Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).
Grade 2 = In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
Grade 3 = In bed > 50% of the time. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
Grade 4 = 100% bedridden. Completely disabled. Cannot carry on any self- care. Totally confined to bed or chair.
Grade 5 = Death
Measured: Subject screening visit to 28 days post last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start4 Jul 2017
- Primary completion12 Nov 2019
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment: protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASLAN Pharmaceuticals
- Sponsor type
- University, hospital or other
- Collaborators
- bioRASI, LLC, CMIC Co, Ltd. Japan, Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093870
- Sponsor's protocol ID
- ASLAN001-009
- Acronym
- TreeTopp
- Status last verified
- Jun 2021
- First submitted
- 16 Mar 2017
- Last updated
- 3 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Varlitinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as Second Line Systemic Therapy
- ClinicalTrials.gov ID
- NCT03093870
- Acronym / sponsor ID
- TreeTopp / ASLAN001-009
- Conditions
- Biliary Tract Cancer
- Keywords
- Neoplasms, Biliary Tract Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- ASLAN PharmaceuticalsUniversity, hospital or other
- Collaborators
- bioRASI, LLC, CMIC Co, Ltd. Japan, Syneos Health
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 3 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine
Detailed description
Part 1 of study(Phase 2) is planned to have 120 patients and anticipated completion on July 2019. Recruitment completed.
Part 2 of study(Phase 3) is planned to have 350 patients and anticipated completion on Dec 2022. Not yet recruiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Treatment: protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition
| Arm | Type | Receives |
|---|---|---|
| Varlitinib and Capecitabine | Experimental | Drug: Varlitinib, Drug: Capecitabine |
| Placebo and Capecitabine | Placebo comparator | Drug: Capecitabine, Drug: Placebo (for Varlitinib) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Are of or older than the legal age in the respective countries at the time when written informed consent is obtained
- Have histologically or cytologically confirmed advanced (unresectable) or metastatic biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma (CCA), gallbladder cancer and carcinoma of Ampulla of Vater. This includes clinical diagnosis of biliary tract cancer with histological confirmation of adenocarcinoma.
- Have received and failed one and only one prior line of systemic treatment for advanced or metastatic disease with radiologic evidence of disease progression. This prior line of systemic treatment must also contain gemcitabine
- Have received at least 6 doses of gemcitabine containing treatment in first line (Adjuvant therapy is not regarded as 1st line therapy)
- Have radiographically measurable disease based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as assessed by Independent Central Review (ICR) (For Part 1)
Key exclusion criteria (19 listed)
- Are currently on or have received anti-cancer therapy within the past 3 weeks before receiving the first dose of study medication
- Are currently on or have received radiation or local treatment within the past 3 weeks for the target lesion(s) before receiving the first dose of study medication
- Have evidence of multiple (≥ 2) peritoneal metastases or ascites at baseline as assessed by ICR (For Part 1). (Ascites which can be attributed by non-malignant causes is not excluded. Minimal ascites, which does not require paracentesis is permitted.)
- Have had major surgical procedures within 14 days prior to first dose of study medication
- Have a known metastatic brain lesion(s), including asymptomatic and well controlled lesion(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VarlitinibAlso: ASLAN001, ARRY-334543, QBT01Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death. | Drug | Varlitinib and Capecitabine |
| Capecitabine1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death. | Drug | Placebo and Capecitabine, Varlitinib and Capecitabine |
| Placebo (for Varlitinib)oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death | Drug | Placebo and Capecitabine |
Primary outcome
Objective Response Rate (ORR) - Part 1
Time frame: Data obtained up until progression, or until last evaluable assessment in the absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.
Part 1: The ORR was defined as the number (%) of subjects with ≥ 1 visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or until last evaluable assessment in the absence of progression, was included in the assessment of ORR, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression. Best overall RECIST Response (BOR) was calculated based on the overall visit responses from each RECIST assessment, i.e. the best response a subject had following randomization and prior to RECIST progression or the last evaluable assessment in the absence of RECIST progression. Categorization of BOR was based on the RECIST criteria using the following response categories: CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE).
Progression-free Survival (PFS) - Part 1
Time frame: Time from randomization until date of objective disease progression or death (by any cause in absence of disease progression) regardless of whether subject withdrew from randomized therapy or received another antitumor therapy prior to PD, up to 2 years.
Part 1: Progression-free survival (PFS) was defined as the time from randomization (or starting treatment for the Safety Lead-in) until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the subject withdrew from randomized therapy or received another antitumor therapy prior to disease progression. Subjects who did not experience disease progression or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. However, if the patient progressed or died after ≥ 2 missed visits (12 weeks ± 5 days maximum), the subject was censored at the time of the latest evaluable RECIST assessment. The PFS time was based on the scan/assessment dates rather than visit dates.
13 secondary outcomes
Object Response Rates (ORR) - Safety Lead-In
Time frame: Data obtained up until progression, or until last evaluable assessment in absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.
Overall Survival (OS) - Part 1
Time frame: Time from the date of randomization until death due to any cause, up to 2 years
Overall Survival (OS) - Safety Lead-In
Time frame: Time from the date of randomization until death due to any cause, up to 2 years
Duration of Response (DoR) - Part 1
Time frame: Time from the date of first documented response until the date of documented PD or death in the absence of disease progression, up to 2 years
Disease Control Rate DCR - Part 1
Time frame: Number (%) of subjects with ≥ 1 visit response of CR or PR, or with SD for a minimum of 12 weeks (± 5 days) from randomization.
Tumor Size - Part 1
Time frame: Week 12
Number of Participants With Clinically Significant Laboratory Tests- Safety Lead-in
Time frame: Subject screening visit to 28 days post last study drug administration
Number of Participants With Clinically Significant Laboratory Tests - Part 1
Time frame: Subject screening visit to 28 days post last study drug administration
Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Safety Lead-In
Time frame: Subject screening visit to 28 days post last study drug administration
Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1
Time frame: Subject screening visit to 28 days post last study drug administration
Number of Participants With ECG Parameters of Interest - Safety Lead-In
Time frame: Subject screening visit to 28 days post last study drug administration
Number of Participants With ECG Parameters of Interest - Part 1
Time frame: Subject screening visit to 28 days post last study drug administration
ECOG Performance Status - Part 1
Time frame: Subject screening visit to 28 days post last study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Varlitinib and Capecitabine in people with Biliary Tract Cancer, run by ASLAN Pharmaceuticals at 21 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia, China, Hong Kong, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) - Part 1 (time frame: Data obtained up until progression, or until last evaluable assessment in the absence of progression, regardless of whether subjects discontinued treatment or received a subsequent therapy prior to progression, up to 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.