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Completed

NCT Number: NCT02949895

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

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

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Takatsuki-shi, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986012

Drug

Cisplatin

Drug

etoposide

Drug

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 2 years

  2. Number of participants with serious adverse events (SAEs )

    Time frame: Up to 2 years

  3. Number of Discontinuations due to AEs

    Time frame: Up to 2 years

  4. Number of Deaths due to AEs

    Time frame: Up to 2 years

  5. Number of participants with laboratory toxicity grade shift from baseline

    Time frame: Up to 2 years

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose

  2. Time of maximum observed serum concentration(Tmax)

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose

  3. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose

  4. Observed serum concentration at the end of a dosing interval(Ctau)

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose

  5. Area under the concentration-time curve in 1 dosing interval(AUC(TAU))

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose

  6. Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose

  7. Best overall response (BOR)

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years

  8. Duration of response (DOR)

    Time frame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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