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 June 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01292655
First received: January 26, 2011
Last updated: March 28, 2013
Last verified: June 2012
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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
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 2C4 | |
| 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: | March 28, 2013 |
| 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 May 19, 2013