Study to Evaluate the Safety and Tolerability of Weekly IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

This study is currently recruiting participants.
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01292655
First received: January 26, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.


Condition Intervention Phase
Cancer
Drug: BMS-906024
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 Advanced Solid Tumors

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 event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Tumor assessments at least every 8 weeks during treatment period. ] [ Designated as safety issue: No ]
  • PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells and plucked hair follicles) and tumor biopsies [ Time Frame: PD changes from baseline during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax). [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin). [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC). [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax). [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half). [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index. [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: March 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-906024
Escalation Phase and Expansion Phase
Drug: BMS-906024
Solution for intravenous (IV) administration, Escalating doses starting at 0.3 mg, (Expansion - to be determined), Once weekly, Continuously until disease progression or unacceptable toxicity
Other Name: BMS-906024 (Notch inhibitor)

  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 advanced or metastatic solid tumors (non-hematologic) refractory to or relapsed from standard therapies or for which there is no know effective treatment during dose escalation.
  • Subjects with colorectal cancer, non-small cell lung cancer, triple-negative breast or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
  • Biopsy accessible tumor (may be waived under certain circumstances)
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Infection
  • Elevated triglycerides
  • Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease (IBD))
  • Taking medications known to increase risk of Torsades De Pointes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292655

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, California
Anthony El-Khoueiry, Md Recruiting
Los Angeles, California, United States, 90033
Contact: Anthony El-Khoueiry, Site 003    323-865-3367      
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Patricia Mucci Lorusso, Site 002         
United States, Mississippi
Local Institution Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Site 0006         
United States, Texas
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0005         
Australia, Victoria
Local Institution Recruiting
Parkville, Victoria, Australia, 3050
Contact: Site 004         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 001         
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: NCT01292655     History of Changes
Other Study ID Numbers: CA216-001
Study First Received: January 26, 2011
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on April 17, 2014