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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793897
• Other study ID #: CA191-005
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2008
• Last updated: July 12, 2012
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaKorea: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, 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 in combination with paclitaxel and carboplatin for Phase 2 studies

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy

• 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

• Evidence of > Grade 1 peripheral neuropathy

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• BMS-754807
Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request
• Paclitaxel
Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
• Carboplatin
Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, 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	Parville	Victoria
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Hamilton	Ontario
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Canada,  Korea, Republic of, 

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: starting with dosing on Day 1 until after 30 day follow-up following the last dose	Yes
Secondary	Pharmacodynamics: Biochemical parameters of drug action in serum		assessed every 6 weeks of the study	No
Secondary	Metabolic measures: Effects of the drug on parameters of glucose homeostasis		assessed every 6 weeks of the study	Yes
Secondary	Efficacy Measures: PET scans and tumor assessments by CT/MRI		a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks	No
Secondary	Pharmacokinetic Measures: Blood samples will be collected during pre-specified times		Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)	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