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Advanced or Metastatic Biliary Tract CancerPhase 2NCT03129074

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

A Phase 2 study testing Varlitinib and Capecitabine in people with Advanced or Metastatic Biliary Tract Cancer, run by ASLAN Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of the study is to assess the efficacy of varlitinib in combination with capecitabine as measured by objective response rate (ORR) assessed by independent central review (ICR), based on RECIST v1.1 criteria. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Varlitinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2018to Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are of or older than the legal age in the respective countries at the time when written informed consent is obtained.
  • Are able to understand and willing to sign the informed consent form.
  • Have histologically confirmed diagnoses of relapsed, locally advanced (unresectable) or metastatic biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer and carcinoma of Ampulla of Vater.
  • Have eligible tumor tissue (archival or fresh) for the evaluation of relevant primary endpoints.
  • (Note: For patients without eligible tumor tissue, a discussion with the sponsor is mandatory).
  • Have radiographically measurable disease as determined by the investigator based on the RECIST v1.1 criteria.
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  • 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 1.5 x upper level of normal (ULN).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have an estimated life expectancy of more than 3 months, at the time of screening.
  • Have 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 (eGFR) or creatinine clearance (CrCl) > 50 mL/min/1.73m2
  • Hepatic function, as follows:
  • Total bilirubin ≤ 1.5 x ULN
  • aspartate aminotransferase and alanine aminotransferase ≤ 5 x ULN

Who cannot join

  • Have received systemic anti-cancer treatment except (neo-) adjuvant therapy for early stage disease.
  • Are currently on or have received radiation or local treatment within the past 4 weeks for the target lesion(s), prior to screening.
  • Had undergone major surgical procedures within 28 days prior to study cycle 1 day 1.
  • Have a metastatic brain lesion(s), including asymptomatic and well controlled lesion(s).
  • Have malabsorption syndrome, diseases significantly affecting gastrointestinal function, or difficulty in swallowing and retaining oral medications.
  • 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).
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  • Are female patients who are pregnant or breast feeding.
  • Have been previously treated with varlitinib or capecitabine.
  • 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 (≥ CTCAE 4.03 Grade 2), with the exception of anemia, asthenia, and alopecia, from prior administration of another investigational drug and/or prior anti-cancer treatment.
  • Have a known positive test for human immunodeficiency virus, active viral hepatitis C, viral hepatitis B infection with hepatitis B virus DNA exceeding 2000 IU/mL.
  • Have a known history of drug addiction within last 1 year, on the basis of which there could be a higher risk of non-compliance to study treatment.
  • 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 with a history of interstitial lung disease or current interstitial lung disease.
  • 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.
  • Have a baseline corrected QT interval > 450 ms or patients with known long QT syndrome, torsade de pointes, symptomatic ventricular tachycardia, unstable cardiac syndrome in the past 3 months before screening visit, > class 2 NYHA (The New York Heart Association Functional Classification heart failure), > grade 2 CCS (the Canadian Cardiovascular Society Guidelines) angina pectoris, or receiving quinidine, procainamide, disopyramide, amiodarone, dronedarone, arsenic, dofetilide, or sotalol methadone.

About this study

Official title: A Phase 2, Single Arm Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as First-line Systemic Therapy

The purpose of the study is to assess the efficacy of varlitinib in combination with capecitabine as measured by objective response rate (ORR) assessed by independent central review (ICR), based on RECIST v1.1 criteria.

Read the detailed description

Also to explore the role of biomarkers as predictors of response and clinical benefit with varlitinib

Being tested
Varlitinib, Capecitabine
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VarlitinibDrug

    everyday

  • CapecitabineDrug

    from Day 1 to Day 14 followed by 7-day of rest period, every 21 days.

Study groups in NCT03129074
Study groupRoleWhat they receive
Varlitinib given in combination with capecitabineExperimental* PO varlitinib 300 mg BID * PO capecitabine 1000 mg/m2 BID
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)

    Number (%) of patients with at least one visit response of CR or PR. Tumor evaluations will continue until the earlier of disease progression or starting a subsequent anti-cancer therapy.

    Measured: Through study duration, estimated 3 years

  2. Biomarker

    Use Next generation sequencing/Immunohistochemistry to identify relationships between response to varlitinib and mutations or overexpression in human epidermal growth factor receptor (HER) receptors and the downstream signaling proteins, as well as, mutations in selected cancer pathways.

    Measured: Through study duration, estimated 3 years

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    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).

    Measured: Through study duration, estimated 3 years

  2. Overall survival (OS)

    Defined as the time from start of treatment until death by any cause.

    Measured: Through study duration, estimated 3 years

  3. Duration of response (DoR)

    Defined as the time, in days, from the first recorded achievement of a response (PR or above) until time of objective disease progression in the subset of patients classified as responders in the assessment of ORR

    Measured: Through study duration, estimated 3 years

  4. Disease control rate (DCR)

    Defined as the proportion of patients with a best response of stable disease maintained for at least 12 weeks (-5 days), PR or CR as defined by RECIST v1.1 criteria.

    Measured: Through study duration, estimated 3 years

  5. Objective response rate (ORR)

    Defined as the proportion of patients with a best objective response (BOR) of complete response (CR) or partial response (PR), as assessed by the investigator defined by the RECIST v1.1 criteria.

    Measured: Through study duration, estimated 3 years

  6. Incidence of Adverse Events and changes from baseline in safety parameters

    Incidence of Adverse Events, categorized in accordance to CTCAE 4.03 and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests).

    Measured: Through study duration, estimated 3 years

Timeline

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

  1. First posted26 Apr 2017
  2. Study startMay 2018 (estimated)
  3. Primary completionMar 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Why it stopped: sponsor decision

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03129074
Sponsor's protocol ID
ASLAN001-016
Status last verified
May 2018
First submitted
21 Apr 2017
Last updated
23 May 2018
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 Advanced or Metastatic Biliary Tract Cancer, run by ASLAN Pharmaceuticals.

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 18 inclusion and 16 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: withdrawn, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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 3 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?

On the ClinicalTrials.gov record for NCT03129074.

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 23 May 2018.

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