James Ford
A Phase II Study of GSK1363089 (Formerly XL880) for Metastatic Gastric Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
XL880 is a new chemical entity that inhibits multiple tyrosine kinases (RTKs) with growth promoting and angiogenic properties. One of the primary RTK targets of XL880 is c-Met. Because amplification of Met has been associated with the pathogenesis of gastric cancer, inhibition of c-Met by agents such as XL880 may be of therapeutic benefit in this patient population. Subjects will take XL880 capsules orally. Dosing will occur on a 5 days on, 9 days off cycle every 2 weeks for 8 weeks.
Recruiting Status:
RecruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: XL880
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- subject has a histologically confirmed diagnosis of poorly differentiated metastatic gastric carcinoma (subjects with tumors of the gastroesophageal junction may also be eligible)
- tumor tissue samples must be provided
- subject has measurable disease
- subject has ECOG performance status <= 2
- subject is able to ingest XL880 capsules
- in the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level >= 20 ug/dL 30-90 minutes after injection of ACTH
- subject has adequate organ and marrow function
- subject has given written informed consent
- subject 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
- subject has no other diagnosis of malignancy
Key Exclusion Criteria:
- subject has received radiotherapy to >= 25% of his or her bone marrow within 30 days of initial treatment with XL880
- subject has received more than one line of prior cytotoxic chemotherapy for locally advanced or metastatic disease
- subject has received an investigational drug within 30 days of the first dose of XL880
- subject has received chemotherapy, immunotherapy or radiotherapy within 30 days or has received nitrosoureas or mitomycin C within 6 weeks of first dose of XL880
- subject has adverse events due to medications (including investigational agents) administered more than 30 days prior to enrollment that have not recovered to within 10% of baseline or to Grade </= 1
- subject has known brain metastases
- subject has uncontrolled intercurrent illness
- subject is pregnant or breastfeeding
- subject is known to be positive for HIV
- subject has an allergy or hypersensitivity to components of the XL880 formulation
Additional Study Details
Official Title:
A Phase 2 Study of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Metastatic Gastric CanceAnticipated start date:
8/1/2007Lead Sponsor:
ExelixisInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Safety and tolerability
- Response rate
Secondary Outcomes:
- Progression-free survival
- Duration of response
- Overall survival
- Pharmacokinetic and pharmacodynamic parameters
Total Number to be Enrolled:
40Total Number to be Enrolled at Stanford:
8More Information
Secondary ID(s):
- 97850
- GIMTS0001
- NCT00725712
- XL880-204
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
6/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help
Trial Administration