Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer

NCT00920192 | Completed Phase 1

• 1 other identifier: 111645
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 7

Brief Summary

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).

Conditions

Carcinoma, Hepatocellular

Keywords

c-MET; VEGFR2; Advanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• The maximum tolerated dose (MTD)

  up to 2 years

• Safety and tolerability of foretinib at the MTD as measured by number and severity of AEs

  up to 2 years

Secondary Outcomes (2)

• The antitumor activity of foretinib at the MTD according to RECIST

  up to 2 years

• PK profile of foretinib

  21 days

Study Arms (1)

Foretinib

EXPERIMENTAL

Phase I starting dose of 30 mg/day escalated to 45 mg/day, de-escalated to 30 mg/day; MTD for Phase II was 30 mg/day

Drug: Foretinib

Interventions

Foretinib DRUG

Phase I starting dose 30 mg/day escalated to 45 mg/day; de-escalated to 30 mg/day. MTD for Phase II dose was 30 mg/day,

Foretinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Hong Kong, Hong Kong

Location

GSK Investigational Site

Tainan, 70428, Taiwan

Location

GSK Investigational Site

Taipei, 110, Taiwan

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Singh RP, Patel B, Kallender H, Ottesen LH, Adams LM, Cox DS. Population pharmacokinetics modeling and analysis of foretinib in adult patients with advanced solid tumors. J Clin Pharmacol. 2015 Oct;55(10):1184-92. doi: 10.1002/jcph.546. Epub 2015 Jul 7.

  PMID: 25998042 DERIVED

Related Links

• Results for study 111645 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

GSK 1363089

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: August 12, 2009
• Primary Completion: March 7, 2012
• Study Completion: March 24, 2015
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

HK (1); TW (3); TH (3)