Study of BMS-986012 in Subjects With Small Cell Lung Caner

NCT ID: NCT02949895

Last Updated: 2019-08-12

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2017-08-29

Brief Summary

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A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer

Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Dose 1

BMS-986012 Dose Escalation Dose 1

Group Type EXPERIMENTAL

BMS-986012

Intervention Type DRUG

Dose Escalation Dose 2

BMS-986012 Dose Escalation Dose 2

Group Type EXPERIMENTAL

BMS-986012

Intervention Type DRUG

Chemotherapy Combination

BMS-986012 + Cisplatin + Etoposide

Group Type EXPERIMENTAL

BMS-986012

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Interventions

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BMS-986012

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

* Histological or cytological confirmed small cell lung cancer (SCLC)
* Eastern Cooperative Oncology Group Performance Status 0-1
* at least one measurable lesion that is not amenable to resection.
* Adequate organ function

Exclusion Criteria

* Symptomatic central nervous system (CNS) metastases
* Grade ≥ 2 peripheral neuropathy
* Uncontrolled or significant cardiac disease
* Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Takatsuki-shi, Osaka, Japan

Site Status

Local Institution

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA001-045

Identifier Type: -

Identifier Source: org_study_id

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