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A Phase 1/2, Open-Label, Multicenter Study of GSK1363089Gin Adult Subjects With Hepatocellular Carcinoma

Phase 1
18 Years
Open (Enrolling)
Carcinoma, Hepatic Cell

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Trial Information

A Phase 1/2, Open-Label, Multicenter Study of GSK1363089Gin Adult Subjects With Hepatocellular Carcinoma

The purpose of this study is to identify the maximum tolerated dose (MTD) of foretinib (also
known as GSK1363089) when used in the treatment of patients with advanced hepatocellular
carcinoma (liver cancer), and to assess the safety and tolerability of that dose in this
patient population.

The MTD will be identified during Phase I, by standard dose-escalation of foretinib. Then
Phase II will assess the safety and tolerability of foretinib dosed at MTD.

Inclusion Criteria:

- Signed informed consent

- 18 years or older

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Has histologically or cytologically confirmed advanced (unresectable and/or
metastatic) hepatocellular carcinoma (HCC).

- Has adequate organ system function

- Has at least 1 target tumor lesion.

- Has the ability to swallow and retain oral medication

- Has a life expectancy of at least 12 weeks

- If male:

Agrees to use double-barrier contraception, OR Agrees to complete abstinence from sexual
intercourse for 14 days before exposure to investigational product, during the clinical
trial, and for at least 21 days after the last dose of investigational product

- If female: Is of nonchildbearing potential OR Is of childbearing potential and has a
negative serum pregnancy test within 14 days before the first dose of study drug, and
agrees to use adequate contraception.

Exclusion Criteria:

- Has previously used an investigational agent or licensed drug that inhibits multiple
receptor tyrosine kinases

- Is currently receiving cancer therapy

- Is currently receiving treatment with an investigational agent, including an
investigational anticancer agent

- Has a Child-Pugh score >6

- Has AEs due to investigational drugs or other medications administered more than 21
days before enrollment that have not recovered to Grade 1 or less with the exception
of alopecia greater than Grade 1

- Has received local therapy within the following timeframes and the subject has not
fully recovered from the prior therapy: Radiotherapy: less than 28 days since
completion of prior radiotherapy Chemoembolization, hepatic arterial embolization,
percutaneous ethanol injection, or cryoablation: less than 42 days since completion
of prior therapy Radiofrequency ablation: less than 60 days since completion of prior
therapy Surgery: (1) prior surgical procedure affecting absorption, and (2) less than
28 days since last prior major surgery

- Has a history or clinical evidence of central nervous system metastases or
leptomeningeal carcinomatosis

- Has a history of malabsorption syndrome, any medical condition significantly
affecting gastrointestinal function, or resection of the stomach or small bowel

- Has active peptic ulcer disease, inflammatory bowel disease, or other
gastrointestinal condition increasing the risk of perforation, or history of
abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- Has a known immediate or delayed hypersensitivity or idiosyncratic reaction to drugs
chemically related to foretinib.

- Has a QTcB (Bazett-corrected QT interval) or QTcF (Frederica-corrected QT interval)
greater than or equal to 470 msec (or 500 msec if the subject has bundle branch

- Has a history of any one of the following cardiac conditions or procedures within the
past 6 months: Cardiac angioplasty or stenting Myocardial infarction Unstable angina

- Has a history of a cerebrovascular accident within the past 6 months

- Has Class III or IV heart failure as defined by the New York Heart Association
functional classification system

- Has poorly controlled hypertension (systolic blood pressure of 140 mm Hg or greater
or diastolic blood pressure of 90 mm Hg or greater)

- Has a history of untreated deep venous thrombosis within the past 6 months (e.g.,
calf vein thrombosis)

- Has a history of main portal vein thrombosis

- Has the presence of any nonhealing wound, fracture, or ulcer, or the presence of
symptomatic peripheral vascular disease

- Has had previous or concurrent cancer that is distinct in primary site or histology
from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, and
superficial bladder tumors (tumor stages Ta, Tis, and T1). Any cancer curatively
treated more than 3 years before study entry is permitted.

- Has a history of bleeding varices within the past 30 days

- Has had clinically significant gastrointestinal bleeding within the past 30 days

- Is a pregnant or lactating female

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerated dose (MTD)

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Taiwan: Department of Health

Study ID:




Start Date:

September 2009

Completion Date:

June 2013

Related Keywords:

  • Carcinoma, Hepatic Cell
  • c-MET
  • VEGFR2
  • Advanced hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular