NCT01292655

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_1 cancer

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

March 3, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

6.3 years

First QC Date

January 26, 2011

Last Update Submit

January 24, 2020

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events as a measure of safety and tolerability

    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 Outcomes (8)

  • Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1

    Tumor assessments at least every 8 weeks during treatment period

  • PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies

    PD changes from baseline during the first 4-5 weeks of dosing

  • PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)

    PK at multiple time points during the first 8 weeks of dosing

  • PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)

    PK at multiple time points during the first 8 weeks of dosing

  • PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)

    PK at multiple time points during the first 8 weeks of dosing

  • +3 more secondary outcomes

Study Arms (4)

Arm A1 (Escalation): BMS-906024

EXPERIMENTAL

BMS-906024 solution intravenously as specified

Drug: BMS-906024

Arm A2 (Expansion): BMS-906024

EXPERIMENTAL

BMS-906024 solution intravenously as specified

Drug: BMS-906024

Arm B1 (Escalation): BMS-906024

EXPERIMENTAL

BMS-906024 solution intravenously as specified

Drug: BMS-906024

Arm B2 (Expansion): BMS-906024

EXPERIMENTAL

BMS-906024 solution intravenously as specified

Drug: BMS-906024

Interventions

BMS-906024DRUG
Also known as: BMS-906024 (Notch inhibitor)
Arm A1 (Escalation): BMS-906024Arm A2 (Expansion): BMS-906024Arm B1 (Escalation): BMS-906024Arm B2 (Expansion): BMS-906024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Anthony El-Khoueiry, Md

Los Angeles, California, 90033, United States

Location

Winship Cancer Institute.

Atlanta, Georgia, 30322, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University Of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Local Institution

Parkville, Victoria, 3050, Australia

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Chan D, Kaplan J, Gordon G, Desai J. Activity of the Gamma Secretase Inhibitor AL101 in Desmoid Tumors: A Case Report of 2 Adult Cases. Curr Oncol. 2021 Sep 21;28(5):3659-3667. doi: 10.3390/curroncol28050312.

    PMID: 34590610DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-906024

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 9, 2011

Study Start

March 3, 2011

Primary Completion

June 22, 2017

Study Completion

June 22, 2017

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

US(6)CA(1)AU(1)