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Completed

NCT Number: NCT00788333

Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer

This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Kurralta Park, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

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

For additional information on this trial, please call (910) 558-2913

Inclusion criteria

  • Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed
  • Histologic or cytologic diagnosis of Her-2-positive breast cancer
  • ECOG status 0 - 1

Exclusion criteria

  • Symptomatic brain metastasis
  • Any condition requiring chronic use of steroids
  • Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms
  • History of glucose intolerance
  • Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Treatment and study plan

BMS-754807

Drug

Tablets, Oral, Dose escalation to MTD, then MTD to response/EOT, once daily, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop

Other names: IGF-IR

Trastuzumab (Herceptin®)

Drug

IV solution, IV, 4mg/kg Day 1 loading dose, 2mg/kg once weekly, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop

Other names: Herceptin®

Primary outcomes

  1. The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis

    Time frame: Every 30 days until MTD is reached

Secondary outcomes

  1. Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)

    Time frame: Every 8 weeks

  2. Evaluate safety and tolerability of the combination regimen

    Time frame: Ongoing

  3. Assess effect of combination therapy on glucose metabolism

    Time frame: At 30 days, then every 8 weeks

  4. Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia

    Time frame: Ongoing

  5. Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis

    Time frame: Days, 1,8,15,22

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2008
Registry last updated
Jul 13, 2012

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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