Last updated: 11/04/2018 09:12:09
Study of GSK1363089 in metastatic gastric cancer
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 2 Study of GSK1363089 (XL880) Administered Orally to Subjects with Metastatic Gastric Cancer
Trial description: This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in metastatic gastric carcinoma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with Objective response rate (ORR), of GSK1363089, per- Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0
Timeframe: At every 8 Weeks upto 31 months
Number of participants with Adverse event (AE) and Serious adverse event (SAE)
Timeframe: Up to 31 months
Change from Baseline in Vital signs-Systolic and diastolic blood pressure
Timeframe: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)
Change from Baseline in Vital signs-Pulse rate
Timeframe: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)
Change from Baseline in temperature
Timeframe: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)
Change from Baseline in Respiratory rate (RR)
Timeframe: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)
Number of participants with shift from Baseline in by high/low flag for serum chemistry- Ungraded
Timeframe: From Day 1 and before 30-day follow- up (up to 2 years)
Number of participants with shift from Baseline in serum chemistry- Graded
Timeframe: From Day 1 to up to 30-day follow-up visit (up to 2 years)
Number of participants with shift from Baseline by high/low flag for hematology paramaters
Timeframe: From Day 1 and before 30-day follow- up (up to 2 years)
Number of participants with grade shift for urinalysis parameters
Timeframe: From Day 1 and before 30-day follow- up (up to 2 years)
Number of participants with shift from baseline by grade for hematology parameters
Timeframe: Baseline (pre-dose) and before 30-day follow- up (up to 2 years)
Number of participants who required concomitant medications
Timeframe: Baseline (pre-dose) and before 30-day follow- up (up to 2 years)
Secondary outcomes:
Median progression free survival (PFS) of GSK1363089
Timeframe: At every 8 Weeks upto 31 months
Duration of Stable Disease of GSK1363089
Timeframe: At every 8 Weeks upto 31 months
Disease stabilization rate of GSK 1363089
Timeframe: At every 8 Weeks upto 31 months
Median duration of overall survival (OS)of GSK1363089
Timeframe: At every 8 Weeks upto 31 months
Interventions:
Drug: GSK1363089 (formerly XL880)
Enrollment:
74
Observational study model:
Not applicable
Primary completion date:
2009-30-11
Time perspective:
Not applicable
Clinical publications:
Jhawer M, Kindler HL, Wainberg Z, Ford J, Kunz P, Tang L, McCallum S, Kallender H, Shah MA Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancern (GC): Interim results of a multicenter phase II study J Clin Oncol 2009, 27 (15S), 4502.
Jhawer MP, Kindler HL, Wainberg ZA, Hecht JR, Kerr RO, Ford JM, Henderson C, Mueller T, Keer HN, Shah MA Preliminary activity of XL880, a dual MET/VEGFR2 inhibitor, in MET amplified poorly differentiated gastric cancer (PDGC): Interim results of a multicenter phase 2 study. J Clin Oncol, 2008, 26 (15S), Abstr. 4572
Shah M, Wainberg ZA, Catenacci D, Hochster H, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe D, Keer H, Gagnon R, Martin A, Liu Y, Bottaro D. Phase 2 Study Evaluating 2 Dosing Schedules of Oral Foretinib (Formerly GSK1363089) in Patients with Advanced or Metastatic Gastric Cancer. PLoS ONE. 2013;8(3):e54014.
Medical condition
Neoplasms, Gastrointestinal Tract
Product
foretinib
Collaborators
Not applicable
Study date(s)
March 2007 to November 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- histologically confirmed diagnosis of advanced or metastatic gastric carcinoma, or adenocarcinoma of the gastroesophageal junction or of the distal esophagus. Subjects with tumors of the gastroesophageal junction or of the distal esophagus may be eligible provided that the tumor is not of squamous or sarcomatous histology
- Measurable disease
- The subject has received more than two lines of prior cytotoxic chemotherapy for
- locally advanced or metastatic disease. For the purpose of this protocol, neoadjuvant
Inclusion and exclusion criteria
Inclusion criteria:
- histologically confirmed diagnosis of advanced or metastatic gastric carcinoma, or adenocarcinoma of the gastroesophageal junction or of the distal esophagus. Subjects with tumors of the gastroesophageal junction or of the distal esophagus may be eligible provided that the tumor is not of squamous or sarcomatous histology
- Measurable disease
- The subject consents to provide paired tumor biopsies, directly prior to commencing study treatment and then between Days 5 and 8.
- The subject has an ECOG performance status ≤2.
- The subject is able to ingest the GSK1363089 capsules.
- In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥20 μg/dL (552 nmol/L) 30-90 minutes after injection of ACTH.
- The subject has liver, kidney and marrow function.
- The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
- Sexually active subjects (male and female) must use a medically-accepted method of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
- The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago, and has no evidence of disease for 5 years prior to the screening for this study).
- QTc < 470 msec.
Exclusion criteria:
- The subject has received more than two lines of prior cytotoxic chemotherapy for locally advanced or metastatic disease. For the purpose of this protocol, neoadjuvant therapy would not be considered to be prior cytotoxic chemotherapy. In addition, potential subjects who have received prior treatment with c-MET signaling inhibitor are excluded.
- The subject has received an investigational drug within 14 days of the first dose of study drug.
- The subject has received chemotherapy, immunotherapy, or radiation therapy (to ≥25% of his or her bone marrow) within 14 days or has received nitrosoureas or mitomycin C within 6 weeks prior to the scheduled first dose of GSK1363089.
- The subject has AEs due to investigational drugs or other medications administered more than 21 days prior to enrollment that have not recovered to Grade ≤1 using NCI CTCAE v3.0, with the exception of alopecia greater than grade 1.
- The subject has known brain metastases.
- The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject has a previously identified allergy or hypersensitivity to components of the GSK1363089 formulation.
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Trial location(s)
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78705
Status
Will Be Recruiting
Location
GSK Investigational Site
Stanford, California, United States, 94305
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20007
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30309
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90024
Status
Study Complete
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-30-11
Actual study completion date
2009-30-11
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.
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