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

Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01363817
First received: April 22, 2011
Last updated: November 20, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies


Condition Intervention Phase
Lymphoblastic Leukemia, Acute T-cell
Precursor T-Cell Lymphoblastic Lymphoma
Drug: BMS-906024
Drug: Dexamethasone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI) [ Time Frame: Disease assessments at least every 8 weeks during treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax) [ Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin) [ Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: area under the concentration-time curve (AUC) [ Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: time to reach maximum observed concentration (Tmax) [ Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half) [ Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose) [ Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing ] [ Designated as safety issue: No ]
  • Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells) [ Time Frame: Pharmacodynamic sampling: in blood during the first 8 weeks of dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escalation Phase: BMS-906024
BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity
Drug: BMS-906024
Other Name: Notch inhibitor
Experimental: Expansion Phase: BMS-906024 + Dexamethasone
BMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity
Drug: BMS-906024
Other Name: Notch inhibitor
Drug: Dexamethasone
Other Name: Baycadron

Detailed Description:

Minimum Age: 10 years and older at selected sites

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
  • Life expectancy of at least 2 months
  • Performance status (PS) 0-1 (a measure of the ability to carry out activities of daily living); subjects with PS 2 are eligible if due to disease related symptoms
  • Prior anti-cancer treatment permitted (with specific criteria)
  • Adequate organ function

Exclusion Criteria:

  • Infection
  • Elevated triglycerides
  • Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
  • Unable to tolerate bone marrow biopsy
  • Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363817

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel Deangelo, Site 002    617-632-5918      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dan Douer, Site 003    646-497-9127      
United States, Texas
The University Of Texas Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Patrick Zweidler-Mckay, Site 001    713-792-7305      
France
Local Institution Recruiting
Marseille Cedex 9, France, 13273
Contact: Site 005         
Local Institution Recruiting
Paris Cedex 10, France, 75475
Contact: Site 004         
Germany
Local Institution Recruiting
Frankfurt/main, Germany, 60590
Contact: Site 006         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01363817     History of Changes
Other Study ID Numbers: CA216-002, 2010-022727-29
Study First Received: April 22, 2011
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014