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COMPLETEDPHASE2/PHASE3

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

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

NCT03093870•ASLAN Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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:
+9 more criteria

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
+9 more criteria

Locations (21)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Karmanos Cancer Institute/Wayne State University

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

CCCN

Las Vegas, Nevada, United States

Ruttenberg Cancer Center, Mount Sinai Hospital

New York, New York, United States

Levine Cancer Institute, Carolinas Healthcare System

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

UPMC Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Texas Oncology, P.A.

Dallas, Texas, United States

Key Dates

Start Date

July 4, 2017

Primary Completion Date

November 12, 2019

Completion Date

April 17, 2020

Last Updated

August 3, 2021

Enrollment

151

ACTUAL participants

Conditions

Biliary Tract Cancer

Interventions

Varlitinib

DRUG

Capecitabine

DRUG

Placebo (for Varlitinib)

DRUG

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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RECRUITINGPHASE1

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

NCT04900818

Solid TumorAdvanced Cancer+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Cosiporfin Sodium for Injection Photodynamic Therapy

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.