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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: June 25, 2014
Last verified: May 2014

January 26, 2011
June 25, 2014
March 2011
February 2015   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01292655 on ClinicalTrials.gov Archive Site
  • 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 tumor biopsies [ Time Frame: PD changes from baseline during the first 4-5 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 8 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 8 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 8 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 8 weeks of dosing ] [ Designated as safety issue: No ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI) [ Time Frame: PK at multiple time points during the first 8 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 8 weeks of dosing ] [ Designated as safety issue: No ]
  • 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 ]
  • PK parameters for BMS-906024 and its metabolite BMS-911557 including Cmax, Cmin, AUC, Tmax, T-Half and accumulation index. [ Time Frame: PK at multiple time points during the first 4 weeks of dosing. ] [ Designated as safety issue: No ]
    maximum observed concentration (Cmax), minimum observed concentration (Cmin), area under the concentration-time curve (AUC), time to reach maximum observed concentration (Tmax), terminal phase elimination half-life (T-Half)
  • 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 ]
Not Provided
Not Provided
 
Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: BMS-906024
Other Name: BMS-906024 (Notch inhibitor)
  • Experimental: Arm A1 (Escalation): BMS-906024
    BMS-906024 solution intravenously as specified
    Intervention: Drug: BMS-906024
  • Experimental: Arm A2 (Expansion): BMS-906024
    BMS-906024 solution intravenously as specified
    Intervention: Drug: BMS-906024
  • Experimental: Arm B1 (Escalation): BMS-906024
    BMS-906024 solution intravenously as specified
    Intervention: Drug: BMS-906024
  • Experimental: Arm B2 (Expansion): BMS-906024
    BMS-906024 solution intravenously as specified
    Intervention: Drug: BMS-906024
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
February 2015
February 2015   (final data collection date for primary outcome measure)

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 known effective treatment during dose escalation
  • Subjects with squamous non-small cell lung cancer and triple-negative breast cancer 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
Both
18 Years and older
No
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 #.
United States,   Australia,   Canada
 
NCT01292655
CA216-001
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP