Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Meta

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

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https://clinicaltrials.gov/ct2/show/NCT03231176

Purpose
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.

Condition Intervention Phase
Biliary Tract Cancer
Drug: Varlitinib
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Capecitabine
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Aslan Pharmaceuticals:

Primary Outcome Measures:
Objective Response Rate (ORR) [ Time Frame: Through study duration, estimated 2 years ]
Objective Response Rate defined as the proportion of patients with at least one visit 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.

Secondary Outcome Measures:
Progression-free survival (PFS) [ Time Frame: Through study duration, estimated 2 years ]
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.

Disease Control Rate (DCR) [ Time Frame: Through study duration, estimated 2 years ]
Disease control rate is defined as the number (%) of patients with at least one visit response of CR or PR, or with stable disease for a minimum of twelve weeks (- 5 days) from starting treatment

Duration of Response (DoR) [ Time Frame: Through study duration, estimated 2 years ]
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 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.

Overall Survival (OS) [ Time Frame: Through study duration, estimated 2 years ]
Overall Survival is defined as time from the start of treatment until death by any cause.

Incidence of Adverse Events (AEs) [ Time Frame: Through study duration, estimated 2 years ]
Incidence of AEs, categorized in accordance to CTCAE 4.03, and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests)

Estimated Enrollment: 25
Anticipated Study Start Date: November 15, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varlitinib and Capecitabine Drug: Varlitinib
Varlitinib:300mg, 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.
Other Names:
ASLAN001
ARRY-334543
SPS4370
QBT01
Drug: Capecitabine
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.

Eligibility

Ages Eligible for Study: 21 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Patients have 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.
Patients 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
Patients have radiographically measurable disease based on RECIST v1.1.
Patients 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).
Patients are of or older than the legal age in the respective countries 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.
Patients have adequate organ and hematological function:

a. Hematological function, as follows: i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii.Platelet count ≥ 100 x 109/L b. Renal functions, as follows: i. Estimated glomerular filtration rate or creatinine clearance > 50mL/min/1.73m2 c. Hepatic function, as follows: i. Total bilirubin ≤ 1.5 x ULN ii.AST and ALT ≤ 5 x ULN

Exclusion Criteria:

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.
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 have been previously treated with varlitinib or capecitabine.
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03231176

Contacts
Contact: Juliana Wang +65 6222 4235 contact@aslanpharma.com

Sponsors and Collaborators
Aslan Pharmaceuticals
More Information

Responsible Party: Aslan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03231176 History of Changes
Other Study ID Numbers: ASLAN001-008
Study First Received: July 25, 2017
Last Updated: July 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aslan Pharmaceuticals:
Biliary Tract Neoplasms
Bile Duct Neoplasms
Gallbladder Neoplasms

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2017