Trial record 5 of 86 for:    small cell lung ca | Open Studies

Multiple Ascending Dose w/Expansion in Relapsed/Refractory SCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02247349
First received: September 19, 2014
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to determine the safety, tolerability, pharmacokinetics,immunogenicity,antitumor activity and pharmacodynamics of BMS-986012 in subjects with relapsed/refractory SCLC.


Condition Intervention Phase
Small Cell Lung Cancer
Biological: BMS-986012 (anti-fucosyl-GM1)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths [ Time Frame: Weekly for 1st and 2nd 21-day cycles, then once every 3 weeks during study treatment, at end of treatment and every 30 days during clinical follow-up until resolution of adverse events or 100 days after the last dose of study medication (Approx 3 years) ] [ Designated as safety issue: Yes ]
    Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), as appropriate


Secondary Outcome Measures:
  • Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
  • Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
  • Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
  • Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy

  • Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Objective Response Rate (ORR): defined as the total number of subjects whose best overall response (BOR) is either a Complete response (CR) or Partical response (PR) divided by the total number of subjects in the population of interest

  • Duration of Response for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first

  • Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Progression Free Survival (PFS): defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause

  • Progression Free Survival Rate (PFSR) at week "t"; for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Progression Free Survival Rate (PFSR) at week "t": defined as the proportion of subjects who remain progression free and surviving at "t" weeks (t=12, 24, 36, etc)

  • Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Overall Survival (OS): defined as the time between the date of first dose of study medication and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive

  • Overall Survival Rate (OSR) at month "t" for BMS-986012 (anti-fucosyl-GM1) [ Time Frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years) ] [ Designated as safety issue: No ]
    Overall Survival Rate (OSR) at month "t": defined as the proportion of subjects surviving at "t" months (eg, t=6, 12, 24 months, etc)

  • Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up [ Time Frame: Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years) ] [ Designated as safety issue: Yes ]
  • Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment [ Time Frame: At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: October 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Dose -1: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation Dose 1: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation Dose 2: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation Dose 3: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation Dose 4: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion Cohort A: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion Cohort B: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion Cohort C: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion Cohort D: BMS-986012 (anti-fucosyl-GM1)
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks Until disease progression/clinical deterioration, confirmed complete response or unacceptable toxicity
Biological: BMS-986012 (anti-fucosyl-GM1)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histological or cytological confirmed small cell lung cancer (SCLC)
  • Performance Status 0-1
  • Adequate organ function
  • Measurable disease

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247349

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Neal Ready, Site 0001    919-681-6932      
Australia, Victoria
Local Institution Recruiting
East Bentleigh, Victoria, Australia, 3165
Contact: Site 0002         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Quincy (Siu-Chung) Chu, Site 0003    780-989-8157      
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02247349     History of Changes
Other Study ID Numbers: CA001-030, 2014-002372-89
Study First Received: September 19, 2014
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
South Korea: Korea Food and Drug Administration (KFDA)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on April 16, 2015