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Completed

NCT Number: NCT00569036

Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors

This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies

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Key information

Conditions

Neoplasms Metastases Neoplasm Metastasis Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, East Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
  • ECOG performance status 0-1
  • at least 4 weeks between surgery or last dose prior anti-cancer therapy

Exclusion criteria

  • symptomatic brain metastases
  • any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
  • uncontrolled or significant cardiovascular disease
  • inadequate bone marrow, liver or kidney function

Treatment and study plan

BMS-754807

Drug

Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request

Other names: IGF-IR

Primary outcomes

  1. Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3

    Time frame: Continuous assessment throughout the duration of the trial

Secondary outcomes

  1. Pharmacokinetics

    Time frame: assessed during the first 4 weeks of the study

  2. Pharmacodynamics

    Time frame: assessed during the first 4 weeks of the study

  3. Metabolic measures

    Time frame: assessed during the first 4 weeks of the study

  4. ECG

    Time frame: assessed during the first 4 weeks of the study

  5. Efficacy Measures

    Time frame: assessed every 8 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2007
Registry last updated
Aug 14, 2013

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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