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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569036
• Other study ID #: CA191-002
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2007
• Last updated: August 13, 2013
• Start date: April 2008
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastases
• Neoplasms
• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Australia	Local Institution	East Melbourne	Victoria
Australia	Local Institution	Footscray	Victoria
Australia	Local Institution	Heidelberg	Victoria
Australia	Local Institution	Nedlands	Western Australia
Australia	Local Institution	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetics		assessed during the first 4 weeks of the study	No
Secondary	Pharmacodynamics		assessed during the first 4 weeks of the study	No
Secondary	Metabolic measures		assessed during the first 4 weeks of the study	Yes
Secondary	ECG		assessed during the first 4 weeks of the study	Yes
Secondary	Efficacy Measures		assessed every 8 weeks	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form