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

A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With 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

Study Overview

• Status: Completed
• Conditions: Neoplasms; Solid Tumors; Metastases
• Intervention / Treatment: Drug: BMS-754807

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Local Institution
    • Footscray, Victoria, Australia, 3011
      • Local Institution
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution
    • Parkville, Victoria, Australia, 3050
      • Local Institution
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BMS-754807; Single arm, multiple-ascending dose escalation study	Drug: BMS-754807; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3	Continuous assessment throughout the duration of the trial

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	assessed during the first 4 weeks of the study
Pharmacodynamics	assessed during the first 4 weeks of the study
Metabolic measures	assessed during the first 4 weeks of the study
ECG	assessed during the first 4 weeks of the study
Efficacy Measures	assessed every 8 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (ESTIMATE): December 6, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Advanced or Metastatic Solid Tumors or Neoplasms
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CA191-002