Trial record 1 of 1 for:    NCT00526838
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Study of XL228 Administered Intravenously to Subjects With Advanced Malignancies

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00526838
First received: September 6, 2007
Last updated: April 4, 2011
Last verified: April 2011

September 6, 2007
April 4, 2011
September 2007
June 2011   (final data collection date for primary outcome measure)
  • To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies. [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies. [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of XL228 administered as a weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
  • To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a weekly 1-hour IV infusion in subjects with advanced malignancies.
Complete list of historical versions of study NCT00526838 on ClinicalTrials.gov Archive Site
  • To evaluate plasma pharmacokinetics of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies. [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • To evaluate preliminary safety and efficacy of XL228 when administered at the once-weekly MTD [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
To evaluate plasma pharmacokinetics of XL228 administered as a weekly 1-hour IV infusion in subjects with advanced malignancies.
Not Provided
Not Provided
 
Study of XL228 Administered Intravenously to Subjects With Advanced Malignancies
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Advanced Malignancies

The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Lymphoma
Drug: XL228
1-hour IV infusion
  • Experimental: 1
    once-weekly dosing
    Intervention: Drug: XL228
  • Experimental: 2
    twice-weekly dosing
    Intervention: Drug: XL228
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other eligibility requirements must also be met.
  • The subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means.
  • 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 informed consent document 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.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

  • The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug.
  • The subject has received radiation to >25% of his or her bone marrow within 30 days of treatment with XL228.
  • The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
  • The subject has a primary brain tumor. Subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
  • The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • The subject has a psychiatric illness or social situation 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 known allergy or hypersensitivity to components of the XL228 formulation.
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00526838
XL228-002
Not Provided
Natalie Sacks, MD/Vice President, Clinical Research, Exelixis, Inc.
Exelixis
Not Provided
Not Provided
Exelixis
April 2011

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