Clinical trial NCT00793897: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Metastatic Solid Tumors
Keywords: Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
timeFrame: Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose
Secondary outcomes:
measure: Pharmacodynamics: Biochemical parameters of drug action in serum
timeFrame: assessed every 6 weeks of the study
measure: Metabolic measures: Effects of the drug on parameters of glucose homeostasis
timeFrame: assessed every 6 weeks of the study
measure: Efficacy Measures: PET scans and tumor assessments by CT/MRI
timeFrame: a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks
measure: Pharmacokinetic Measures: Blood samples will be collected during pre-specified times
timeFrame: Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Parville
country: Australia
facility: Local Institution
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: