Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of XL281 in Adults With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00451880
First received: March 23, 2007
Last updated: October 11, 2011
Last verified: October 2011

March 23, 2007
October 11, 2011
February 2007
October 2011   (final data collection date for primary outcome measure)
  • Safety, tolerability, and maximum tolerated dose (MTD) of once daily or twice daily oral administration of XL281 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetic/pharmacodynamic/preliminary clinical activity relationship following XL281 administration in different tumor types from subjects treated at the MTD [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • To determine the bioavailability of XL281 under fed and fasted conditions, and with or without the concomitant use of a single dose of famotidine in subjects with solid tumors [ Time Frame: Assessed during the second, third, and fourth week of the first cycle of dosing ] [ Designated as safety issue: No ]
Safety, tolerability, and maximum tolerated dose of daily oral administration of XL281
Complete list of historical versions of study NCT00451880 on ClinicalTrials.gov Archive Site
Plasma pharmacokinetics of once daily or twice daily oral administration of XL281 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
Plasma pharmacokinetics of daily oral administration of XL281
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Non-small-cell Lung Cancer
  • Colorectal Cancer
  • Papillary Thyroid Cancer
  • Melanoma
  • Drug: XL281
    Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
  • Drug: famotidine
    single dose, supplied as 20-mg or 40-mg tablets
    Other Name: Pepcid®
  • Experimental: Arm 1
    XL281 administered once a day
    Intervention: Drug: XL281
  • Experimental: Arm 2
    XL281 administered twice a day
    Intervention: Drug: XL281
  • Experimental: 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.
    Interventions:
    • Drug: XL281
    • Drug: famotidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2011
October 2011   (final data collection date for primary outcome measure)

Key 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.

Key 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.
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00451880
XL281-001
Not Provided
Kanya Rajangam, MD/Senior Manager, Clinical Research, Exelixis, Inc.
Exelixis
Not Provided
Not Provided
Exelixis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP