Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01292655




Registration number
NCT01292655
Ethics application status
Date submitted
26/01/2011
Date registered
9/02/2011
Date last updated
27/01/2020

Titles & IDs
Public title
Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors
Scientific 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
Secondary ID [1] 0 0
CA216-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Arm A1 (Escalation): BMS-906024 - BMS-906024 solution intravenously as specified

Experimental: Arm A2 (Expansion): BMS-906024 - BMS-906024 solution intravenously as specified

Experimental: Arm B1 (Escalation): BMS-906024 - BMS-906024 solution intravenously as specified

Experimental: Arm B2 (Expansion): BMS-906024 - BMS-906024 solution intravenously as specified
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events as a measure of safety and tolerability
Timepoint [1] 0 0
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
Secondary outcome [1] 0 0
Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1
Timepoint [1] 0 0
Tumor assessments at least every 8 weeks during treatment period
Secondary outcome [2] 0 0
PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies
Timepoint [2] 0 0
PD changes from baseline during the first 4-5 weeks of dosing
Secondary outcome [3] 0 0
PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)
Timepoint [3] 0 0
PK at multiple time points during the first 8 weeks of dosing
Secondary outcome [4] 0 0
PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)
Timepoint [4] 0 0
PK at multiple time points during the first 8 weeks of dosing
Secondary outcome [5] 0 0
PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)
Timepoint [5] 0 0
PK at multiple time points during the first 8 weeks of dosing
Secondary outcome [6] 0 0
PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)
Timepoint [6] 0 0
PK at multiple time points during the first 8 weeks of dosing
Secondary outcome [7] 0 0
PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)
Timepoint [7] 0 0
PK at multiple time points during the first 8 weeks of dosing
Secondary outcome [8] 0 0
PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC)
Timepoint [8] 0 0
PK at multiple time points during the first 8 weeks of dosing

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/06/2017
Sample size
Target
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Mississippi
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01292655