Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia

NCT00464113 | Terminated Phase 1 DMC

• 1 other identifier: XL228-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.

Conditions

Chronic Myeloid Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Keywords

Myeloid Leukemia; Lymphocytic Leukemia; Ph+ ALL

Outcome Measures

Primary Outcomes (1)

• Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228

  Assessed at periodic visits

Secondary Outcomes (2)

• Evaluate plasma pharmacokinetics and estimate renal elimination of once-weekly and twice-weekly 1-hour IV infusion of XL228

  Assessed at periodic visits

• Exploratory Outcomes: Evaluate hematologic and cytogenetic response and pharmacodynamic correlates of XL228 activity

  Assessed at periodic visits

Study Arms (2)

1

EXPERIMENTAL

once-weekly dosing

Drug: XL228

2

EXPERIMENTAL

twice-weekly dosing

Drug: XL228

Interventions

XL228 DRUG

1-hour IV infusion

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has a confirmed pathologic diagnosis as evidenced by the presence of the BCR-Abl translocation \[t(9;22)\] by fluorescence in situ hybridization (FISH), cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the following:
• CML
• Chronic phase (CP)
• Accelerated phase (AP)
• Blast phase (BP) OR
• Ph+ ALL
• The subject has one of the following:
• Known T315I Abl mutation
• Known resistance to or intolerance of imatinib and dasatinib
• At least one prior anti-leukemia therapy, including, but not limited to, interferon, imatinib, or dasatinib
• The subject is at least 18 years old.
• The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• The subject has adequate organ function.
• The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
• Sexually active subjects must use an accepted method of contraception during the course of the study.

You may not qualify if:

• The subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of XL228.
• The subject has received an investigational agent or radiotherapy within 28 days of the first dose of XL228.
• The subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease \[GVHD\]) within 28 days prior to the first dose of XL228.
• The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from toxicities related to peripheral stem cell or bone marrow transplant.
• The subject has not recovered to CTCAE v3.0 Grade ≤1 from adverse events (AEs) due to investigational drugs or other medications.
• The subject has known allergy or hypersensitivity to any component of the investigational drug product.
• The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, 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 inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (6)

UCLA School of Medicine

Los Angeles, California, 90095-1678, United States

Location

University of California San Francisco

San Francisco, California, 94143-1270, United States

Location

Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Lymphoid

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (6)