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Study of XL281 in Adults With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of XL281 in Adults With Solid Tumors

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL281 Administered Orally to Subjects With Solid Tumors

NCT00451880•Exelixis

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safest dose of the multiple Raf kinase inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it should be taken, and how well subjects with cancer tolerate XL281. This study will also determine how the body reacts to XL281 when it is taken with and without food, and with and without Pepcid (famotidine), a drug that inhibits stomach acid production.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival. Subjects treated at the MTD (once- or twice- daily) must have a diagnosis of colorectal cancer, non-small-cell lung cancer (no longer recruiting), melanoma, or papillary thyroid cancer. Certain other eligibility requirements must also be met.
•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 anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug.
•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.
+3 more criteria

Locations (6)

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

Key Dates

Start Date

February 1, 2007

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

October 13, 2011

Enrollment

180

ESTIMATED participants

Conditions

CancerNon-small-cell Lung CancerColorectal CancerPapillary Thyroid CancerMelanoma

Interventions

XL281

DRUG

famotidine

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of XL281 in Adults With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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