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Report for Clinical Trial NCT00464113

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia (Ph+ ALL)

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.

NCT00464113 Chronic Myeloid Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
MeSH:Leukemia Leukemia, Myeloid Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Precursor Cell Lymphoblastic Leukemia-Lymphoma Philadelphia Chromosome
HPO:Chronic myelogenous leukemia Leukemia Lymphoid leukemia Myeloid leukemia

1 Interventions

Name: XL228

Description: 1-hour IV infusion
Type: Drug
Group Labels: 2

1 2


Primary Outcomes

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

Time: Assessed at periodic visits

Secondary Outcomes

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

Time: Assessed at periodic visits

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

Time: Assessed at periodic visits

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 T315I

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: 1. CML - Chronic phase (CP) - Accelerated phase (AP) - Blast phase (BP) OR 2. Ph+ ALL 2. 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 3. The subject is at least 18 years old. --- T315I ---



HPO Nodes


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