Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer

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Brief Title

Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer

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

Brief 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. 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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR) - Part 1

Secondary Outcome

 Object Response Rates (ORR) - Safety Lead-In

Condition

Biliary Tract Cancer

Intervention

Varlitinib

Study Arms / Comparison Groups

 Varlitinib and Capecitabine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

151

Start Date

July 4, 2017

Completion Date

April 17, 2020

Primary Completion Date

November 12, 2019

Eligibility Criteria

        Inclusion Criteria:

        Subjects will be eligible for the study if they:

          1. Are of or older than the legal age in the respective countries at the time when
             written informed consent is obtained

          2. 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.

          3. 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

          4. Have received at least 6 doses of gemcitabine containing treatment in first line
             (Adjuvant therapy is not regarded as 1st line therapy)

          5. 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)

          6. 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)

          7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          8. Are able to understand and willing to sign the informed consent form

          9. Have adequate organ and hematological function:

               1. Hematological function, as follows:

                    -  Absolute neutrophil count (ANC) ≥ 1.5 × 109/L

                    -  Platelet count ≥ 100 × 109/L

               2. Renal functions, as follows:

                  • Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73m2

               3. Hepatic function, as follows:

                    -  Albumin ≥ 3 g/dL

                    -  Total bilirubin ≤ 1.5 × ULN

                    -  Aspartate aminotransferase and alanine aminotransferase ≤ 5 × ULN

        Exclusion Criteria:

        Subjects will be ineligible for the study if they:

          1. Are currently on or have received anti-cancer therapy within the past 3 weeks before
             receiving the first dose of study medication

          2. 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

          3. 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.)

          4. Have had major surgical procedures within 14 days prior to first dose of study
             medication

          5. Have a known metastatic brain lesion(s), including asymptomatic and well controlled
             lesion(s)

          6. 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

          7. 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

          8. 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)

          9. Are female patients who are pregnant or breast feeding

         10. 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

         11. Have received any investigational drug (or have used an investigational device) within
             the last 14 days before receiving the first dose of study medication

         12. 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

         13. 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

         14. 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

         15. Need continuous treatment with proton pump inhibitors during the study period

         16. 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

         17. 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

         18. 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)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03093870

Organization ID

ASLAN001-009


Responsible Party

Sponsor

Study Sponsor

Aslan Pharmaceuticals

Collaborators

 bioRASI, LLC

Study Sponsor

, , 


Verification Date

June 2021