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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

July 4, 2017

Primary Completion Date

November 12, 2019

Study Completion Date

April 17, 2020

Conditions
Biliary Tract Cancer
Interventions
DRUG

Varlitinib

Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.

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.

DRUG

Placebo (for Varlitinib)

oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death

Trial Locations (21)

1062

There are 2 sites in Hungary, Budapest

10029

Ruttenberg Cancer Center, Mount Sinai Hospital, New York

11217

There are 5 sites in different cities in Taiwan, Taipei

12221

Texas Oncology, P.A., Dallas

15232

UPMC Cancer Center, Pittsburgh

27705

Duke University Medical Center, Durham

28204

Levine Cancer Institute, Carolinas Healthcare System, Charlotte

37232

Vanderbilt-Ingram Cancer Center, Nashville

48201

Karmanos Cancer Institute/Wayne State University, Detroit

63110

Washington University School of Medicine, St Louis

77030

UT MD Anderson Cancer Center, Houston

85234

Banner MD Anderson Cancer Center, Gilbert

89169

CCCN, Las Vegas

169610

There are 2 sites in Singapore., Singapore

210031

There are 6 sites in different cities in China, Nanjing

Unknown

There are 5 sites in different cities in Australia, Camperdown

There are 2 sites in Hong Kong, Hong Kong

There are 7 sites in different cities in Japan, Chiba

There are 15 sites in different cities in South Korea, Seoul

05-400

There are 2 sites in different cities in Poland, Otwock

08035

There are 5 sites in different cities in Spain, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

bioRASI, LLC

INDUSTRY

collaborator

CMIC Co, Ltd. Japan

INDUSTRY

collaborator

Syneos Health

OTHER

lead

ASLAN Pharmaceuticals

OTHER