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Varlitinib

Generic Name
Varlitinib
Drug Type
Small Molecule
Chemical Formula
C22H19ClN6O2S
CAS Number
845272-21-1
Unique Ingredient Identifier
846Y8197W1
Background

Varlitinib is an oral, selective, reversible, small molecule tyrosine kinase inhibitor of both ErbB-2 (Her-2/neu) and EGFR. Over-expression of ErbB-2 and EGFR receptors in tumors is predictive of poor prognosis in cancer patients. Varlitinib has shown significant anti-tumor activity in preclinical models of human breast, lung, and epidermal carcinoma tumors.

Indication

Investigated for use/treatment in cancer/tumors (unspecified).

Phase 1b of ASLAN001 (Varlitinib) in Patients With Advanced/ Metastatic Hepatocellular Carcinoma (HCC)

Phase 1
Conditions
Advanced/ Metastatic Hepatocellular Carcinoma
Interventions
First Posted Date
2018-04-17
Last Posted Date
2018-04-17
Lead Sponsor
National University Hospital, Singapore
Target Recruit Count
22
Registration Number
NCT03499626
Locations
🇸🇬

National University Hospital, Singapore, Singapore

Open, Single-dose/-Period Study to Assess Mass Balance Recovery, Metabolite Profile/Identification of 14C-Varlitinib

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2017-12-11
Last Posted Date
2018-09-11
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
6
Registration Number
NCT03368846
Locations
🇬🇧

Quotient Clinical Ltd, Nottingham, United Kingdom

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

Phase 2
Completed
Conditions
Biliary Tract Cancer
Interventions
First Posted Date
2017-07-27
Last Posted Date
2020-11-19
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
62
Registration Number
NCT03231176
Locations
🇨🇳

No.81 Hospital of The Chinese People's Liberation Army, Nanjing, China

🇨🇳

There is 22 sites located in other cities of China, including Nanjing, Nanjing, China

Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)

Phase 2
Completed
Conditions
Gastric Cancer
Interventions
Drug: Placebo
Drug: mFOLFOX6
First Posted Date
2017-04-26
Last Posted Date
2022-02-15
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
52
Registration Number
NCT03130790
Locations
🇰🇷

11 Sites, Seoul, Korea, Republic of

🇹🇭

1 Site, Pathum Thani, Thailand

🇲🇾

2 Sites, Kuala Lumpur, Malaysia

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

Phase 2
Withdrawn
Conditions
Advanced or Metastatic Biliary Tract Cancer
Interventions
First Posted Date
2017-04-26
Last Posted Date
2018-05-23
Lead Sponsor
ASLAN Pharmaceuticals
Registration Number
NCT03129074

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

Phase 2
Completed
Conditions
Biliary Tract Cancer
Interventions
Drug: Placebo (for Varlitinib)
First Posted Date
2017-03-28
Last Posted Date
2021-08-03
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
151
Registration Number
NCT03093870
Locations
🇺🇸

Karmanos Cancer Institute/Wayne State University, Detroit, Michigan, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

🇯🇵

There are 7 sites in different cities in Japan, Chiba, Japan

and more 18 locations

A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours

Phase 1
Completed
Conditions
Advanced or Metastatic Biliary Tract Cancer
Advanced or Metastatic Solid Tumors
Interventions
First Posted Date
2017-03-17
Last Posted Date
2018-06-28
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT03082053
Locations
🇯🇵

ASLAN Selected sites, Tokyo, Japan

Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC

Phase 1
Terminated
Conditions
Biliary Tract Cancer
Interventions
First Posted Date
2016-12-14
Last Posted Date
2021-01-14
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
204
Registration Number
NCT02992340

Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-FU or Cisplatin and Capecitabine

First Posted Date
2016-01-07
Last Posted Date
2018-10-25
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
31
Registration Number
NCT02648425
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

🇨🇳

Taipei Veterans General Hospital, Taipei, Taiwan

🇭🇰

Queen Mary Hospital, Hong Kong, Hong Kong

ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy

Phase 2
Completed
Conditions
Cholangiocarcinoma
Interventions
First Posted Date
2015-11-20
Last Posted Date
2018-05-29
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
32
Registration Number
NCT02609958
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