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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-03

Study Completion Date

2017-06-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A1 (Escalation): BMS-906024

BMS-906024 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-906024

Intervention Type DRUG

Arm A2 (Expansion): BMS-906024

BMS-906024 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-906024

Intervention Type DRUG

Arm B1 (Escalation): BMS-906024

BMS-906024 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-906024

Intervention Type DRUG

Arm B2 (Expansion): BMS-906024

BMS-906024 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-906024

Intervention Type DRUG

Interventions

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BMS-906024

Intervention Type DRUG

Other Intervention Names

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BMS-906024 (Notch inhibitor)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No