First in Human Study to Determine the Safety, Tolerabilit... | NCT01120457

NCT01120457

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Dose Escalation and Expansion cohort (AML Patients)	Experimental	Dose Escalation: BMS-936564 0.3-10 mg/kg solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle) Dose Expansion: BMS-936564 maximum tolerated dose (MTD) based on dose escalation, solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle)	Drug: BMS-936564 (Anti-CXCR4)
Arm 2: Dose Expansion cohort (DLBCL Patient)	Experimental	BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle)	Drug: BMS-936564 (Anti-CXCR4)
Arm 3: Dose Expansion cohort (CLL Patient)	Experimental	BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle)	Drug: BMS-936564 (Anti-CXCR4)
Arm 4: Dose Expansion cohort (FL Patient)	Experimental	BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle)	Drug: BMS-936564 (Anti-CXCR4)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-936564 (Anti-CXCR4)	Drug		Arm 1: Dose Escalation and Expansion cohort (AML Patients) Arm 2: Dose Expansion cohort (DLBCL Patient) Arm 3: Dose Expansion cohort (CLL Patient) Arm 4: Dose Expansion cohort (FL Patient)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability as monotherapy	Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities	Within the first 7 days for AML
Safety and tolerability as monotherapy	Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities	Within 28 days for the selected B-cell malignancies

Secondary Outcomes

Measure	Description	Time Frame
Safety, as measured by vital signs, clinical laboratory tests,ECOG performance status, physical exams, 12 lead ECGs incidence and severity of adverse events	ECOG - Eastern Cooperative Oncology Group ECG - Electrocardiograms	For a maximum of thirteen 28-day cycles for the AML cohort and for a maximum of six 28-day cycles for the B-cell malignancies

Eligibility Module

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

A. Common to All Indications:

B. For Acute myelogenous leukemia (AML) Subjects:

First Relapse and primary induction failure in AML (M3 excluded)
Secondary AML subjects from myelodysplastic syndrome (MDS) or prior chemotherapy are eligible. MDS-only subjects are not eligible

C. For Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL) Subjects:

Must be at least 4 weeks (for FL) or 2 weeks (for DLBCL) since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy
Ability to undergo tumor biopsy pre-treatment and at end of monotherapy period (though not mandatory for all subjects)
Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease

D. For Chronic lymphocytic leukemia (CLL) Subjects:

Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease
Must be at least 4 weeks since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy, including corticosteroids

Exclusion Criteria:

A. Common to All indications:

B. For AML Subjects:

C. For FL, DLBCL Subjects:

(For DLBCL): Inadequate renal function defined as creatinine clearance (by Cockcroft-Gault formula) < 60 mL/min
Major surgery, not related to debulking procedures, within 21 days of first dose
Myocardial infarction within 6 months prior to screening or Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Myelodysplastic syndrome (MDS)

D. For CLL Subjects:

No progression to more aggressive B-cell cancers, such as Richter's syndrome
Major surgery within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator
Myocardial infarction within 6 months prior to screening Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia

Facility	Status	City	State	ZIP	Country	Contacts
Uab Comprehensive Cancer Center		Birmingham	Alabama	35294	United States
Uc San Diego Moores Cancer Center

ID	Term
D015470	Leukemia, Myeloid, Acute
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008224	Lymphoma, Follicular

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma