AzTrials
AzTrials

Biliary Tract CancerPhase 2NCT03231176

Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer

A Phase 2 study testing Varlitinib and Capecitabine in people with Biliary Tract Cancer, run by ASLAN Pharmaceuticals at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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?
Ages 18 to 99 years
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?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesChina
Study dates
19 Dec 2017to 13 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically or cytologically confirmed advanced (unresectable) or metastatic biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer and carcinoma of the Ampulla of Vater. This includes clinical diagnosis of biliary tract cancer with histological confirmation of adenocarcinoma.
  • Patients who have received and failed one and only one prior line of systemic treatment or advanced or metastatic disease with radiologic evidence of disease progression. This prior line of systemic treatment must also contain gemcitabine
  • Patients with radiographically measurable disease based on RECIST v1.1.
  • Patients with 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 1.5 x upper level of normal (ULN).
  • Patients who are or older than 18 years of age and of or younger than 99 years of age at the time when written informed consent is obtained, and are able to understand and willing to sign the informed consent form.
  • Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Show all 15Show fewer
  • Patients with adequate organ and hematological function:
  • Hematological function, as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Renal functions, as follows:
  • Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73m2
  • Hepatic function, as follows:
  • Total bilirubin ≤ 1.5 x ULN
  • AST and ALT ≤ 5 x ULN

Who cannot join

  • Patients are currently on or have received anti-cancer therapy within the past 3 weeks.
  • Patients are currently on or have received radiation or local treatment within the past 3 weeks for the target lesion(s).
  • Patients have had major surgical procedures within 14 days prior to study entry.
  • Patients have a metastatic brain lesion(s), including asymptomatic and well controlled lesion(s).
  • Patients have malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications.
  • Patients have any history or presence of clinically significant condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results.
Show all 15Show fewer
  • Patients have any history of other malignancy unless in remission for more than 1 year. (skin carcinoma and carcinoma-in-site of uterine cervix treated with curative intent is not exclusionary).
  • Female patients are pregnant or breast feeding.
  • Patients who 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 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.
  • Patients have received any investigational drug (or have used an investigational device) within the last 14 days before receiving the first dose of study medication.
  • Patients have unresolved or unstable serious toxicity (≥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.
  • Patients have a known positive test for HIV, active hepatitis C, or hepatitis B infection with hepatitis B virus deoxyribonucleic acid exceeding 2000 IU/mL.
  • Patients have a known history of drug addiction within last 1 year, on the basis that there could be a higher risk of non-compliance to investigational product.
  • Patients need continuous treatment with proton pump inhibitors during the study period.
  • Patients have a baseline corrected QT interval QTc> 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, > grade 2 Canadian cardiovascular society angina pectoris, or receiving quinidine, procainamide, disopyramide, amiodarone, dronedarone, arsenic, dofetilide, or sotalol methadone.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • No.81 Hospital of The Chinese People's Liberation Army

    Nanjing

  • There is 22 sites located in other cities of China, including Nanjing

    Nanjing

Other trials in China

About this study

Official title: A Phase 2A, Single Arm, Multicentre, Study of Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer Who Progressed on at Least 1 Line of 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. Eligible patients will receive Varlitinib plus capecitabine.

Being tested
Varlitinib, Capecitabine
Keywords
Biliary Tract Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms
Medical subject headings
Biliary Tract 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

    oral tablets, twice daily

  • CapecitabineDrug

    oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles

Study groups in NCT03231176
Study groupRoleWhat they receive
Varlitinib and CapecitabineExperimentalNot described
Receives: Drug: Varlitinib; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective Response Rate defined as the proportion of patients with a confirmed best response of partial response (PR) or complete response (CR), as defined by RECIST v1.1 criteria, based on an Independent Central Review (ICR) of radiological data.

    Measured: Through study duration, estimated 2 years

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    Progression Free Survival defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined in accordance with the RECIST v1.1 criteria and will be derived using data from the ICR.

    Measured: Through study duration, estimated 2 years

  2. Disease Control Rate (DCR)

    Disease control rate is defined as the number (%) of patients with a confirmed response of CR or PR, or with stable disease for a minimum of twelve weeks (- 5 days) from starting treatment.

    Measured: Through study duration, estimated 2 years

  3. Duration of Response (DoR)

    The Duration of Response is 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, in the subset of patient classified as confirmed responders for the assessment of ORR. The end of response should coincide with the date of disease progression or death from any cause used for the PFS endpoint. DoR will be calculated using the ICR data.

    Measured: Through study duration, estimated 2 years

  4. Overall Survival (OS)

    Overall Survival is defined as time from the start of treatment until death by any cause.

    Measured: Through study duration, estimated 2 years

  5. Safety and tolerability of varlitinib when combined with capecitabine

    Incidence of AEs, categorized in accordance to CTCAE 4.03, and changes from baseline in safety parameters

    Measured: Through study duration, estimated 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2017
  2. Study start19 Dec 2017
  3. Primary completion5 Jul 2019
  4. Study completion13 Apr 2020

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03231176
Sponsor's protocol ID
ASLAN001-008
Status last verified
Nov 2020
First submitted
25 Jul 2017
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Varlitinib and Capecitabine in people with Biliary Tract Cancer, run by ASLAN Pharmaceuticals at 2 sites in China.

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 15 inclusion and 15 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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) (time frame: Through study duration, estimated 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03231176.

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 19 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in