Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
180 participants
INTERVENTIONAL
2007-02-28
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
XL281 administered once a day
XL281
Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
Arm 2
XL281 administered twice a day
XL281
Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
Arm 3
XL281 administered once a day. Subjects in this arm will be dosed under fed conditions, fasted conditions, and with a concomitant single dose of 40 mg famotidine, during the second, third, and fourth week of the first cycle.
XL281
Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
famotidine
single dose, supplied as 20-mg or 40-mg tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XL281
Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
famotidine
single dose, supplied as 20-mg or 40-mg tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The subject is ≥18 years old.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* The subject has adequate organ and marrow function.
* The subject is capable of understanding the protocol and has signed the informed consent document.
* Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study and for 3 months after study drug discontinuation.
* Female subjects of childbearing potential must have a negative pregnancy test at screening.
* The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed ≥5 years ago, and has had no evidence of disease for 5 years prior to screening for this study).
* The subject must meet certain other eligibility requirements.
Exclusion Criteria
* The subject has received treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within a certain amount of time before the first dose of study drug.
* The subject has received any other investigational agent within 28 days of first dose of XL281.
* The subject has not recovered to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment. Some irreversible toxicities from previous treatment may be allowed.
* The subject requires treatment with antacids (continual treatment), proton pump inhibitors, or H2 receptor antagonists.
* The subject has a primary brain tumor or known brain metastases.
* The subject has an 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 an allergy or hypersensitivity to components of the XL281 formulation or to famotidine.
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
* The subject is receiving anticoagulation with warfarin or coumarin-related compounds (low-dose warfarin ≤ 1 mg/day, heparin, and low-molecular weight heparin are permitted)
* The subject must meet certain other eligibility requirements.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Exelixis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Exelixis, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Premiere Oncology of Arizona
Scottsdale, Arizona, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XL281-001
Identifier Type: -
Identifier Source: org_study_id