BMS-986012 in Relapsed/Refractory SCLC

Phase 1

• Conditions: Small Cell Lung Cancer; MedDRA version: 18.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002372-89-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-07
• Last Update Posted: 21 July 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Histological or cytological confirmed SCLC
• Performance Status 0-1
• Adequate organ function
• Measurable disease

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

• Known or suspected brain metastasis
• Small cell cancer not lung in origin
• Significant or acute medical illness
• Uncontrolled or significant cardiac disease
• Infection
• > Grade 2 peripheral neuropathy
• Concomitant malignancies
• HIV related disease or known or suspected HIV+
• Hepatitis B or C infection
• ECG abnormalities as defined by the protocol
• Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified