Last updated: 11/07/2018 03:40:21
Safety study of foretinib (GSK1363089) in adults with liver cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 1/2, Open-Label, Multicenter Study of GSK1363089Gin Adult Subjects with Hepatocellular Carcinoma
Trial description: The purpose of this study is to assess the safety and tolerability of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
The maximum tolerated dose (MTD)
Timeframe: up to 2 years
Safety and tolerability of foretinib at the MTD as measured by number and severity of AEs
Timeframe: up to 2 years
Secondary outcomes:
The antitumor activity of foretinib at the MTD according to RECIST
Timeframe: up to 2 years
PK profile of foretinib
Timeframe: 21 days
Interventions:
Enrollment:
45
Primary completion date:
2012-07-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Thomas Yau, Riccardo Lencioni, Wattana Sukeepaisarnjaroen, Yee Chao, Chia-Jui Yen, Wirote Lausoontornsiri6 Pei-Jer Chen, Theeranun Sanpajit, Aaron Camp, Donna S. Cox, Robert Gagnon, Yuan Liu, Kristen E. Raffensperger, Diptee Kulkarni, Howard Kallender, Lone Harild Ottesen, Ronnie T.P. Poon, Donald P. Bottaro. Resubmission: A Phase I/II Multicenter Study of Single-Agent Foretinib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma. Clin. Cancer Res.. 2017;23(10):
Medical condition
Carcinoma, Hepatocellular
Product
foretinib
Collaborators
Not applicable
Study date(s)
August 2009 to March 2015
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Signed informed consent
- 18 years or older
- Has previously used an investigational agent or licensed drug that inhibits multiple
- receptor tyrosine kinases
Inclusion and exclusion criteria
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 block).
- 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2012-07-03
Actual study completion date
2015-24-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 111645 can be found on the GSK Clinical Study Register.
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