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Completed

NCT Number: NCT01292655

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

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

BMS-906024

Drug

Other names: BMS-906024 (Notch inhibitor)

Primary outcomes

  1. Number of subjects with adverse events as a measure of safety and tolerability

    Time frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year

Secondary outcomes

  1. Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1

    Time frame: Tumor assessments at least every 8 weeks during treatment period

  2. PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies

    Time frame: PD changes from baseline during the first 4-5 weeks of dosing

  3. PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)

    Time frame: PK at multiple time points during the first 8 weeks of dosing

  4. PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)

    Time frame: PK at multiple time points during the first 8 weeks of dosing

  5. PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)

    Time frame: PK at multiple time points during the first 8 weeks of dosing

  6. PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)

    Time frame: PK at multiple time points during the first 8 weeks of dosing

  7. PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)

    Time frame: PK at multiple time points during the first 8 weeks of dosing

  8. PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC)

    Time frame: PK at multiple time points during the first 8 weeks of dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2011
Registry last updated
Jan 27, 2020

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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