NCT00793897

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

November 17, 2008

Last Update Submit

July 12, 2012

Conditions

Advanced Solid TumorsMetastatic Solid Tumors

Keywords

Subjects with Advanced or Metastatic Solid Tumors or Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Pharmacodynamics: Biochemical parameters of drug action in serum

    assessed every 6 weeks of the study

  • Metabolic measures: Effects of the drug on parameters of glucose homeostasis

    assessed every 6 weeks of the study

  • 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

  • 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)

Study Arms (1)

Sequential allocation of patients in two dosing schedules

EXPERIMENTAL
Drug: BMS-754807Drug: PaclitaxelDrug: Carboplatin

Interventions

BMS-754807DRUG

Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request

Also known as: IGF-IR
Sequential allocation of patients in two dosing schedules
PaclitaxelDRUG

Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Also known as: Taxol, BMS-181339
Sequential allocation of patients in two dosing schedules
CarboplatinDRUG

Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Also known as: Paraplatin, BMY-26575
Sequential allocation of patients in two dosing schedules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Local Institution

East Melbourne, Victoria, 3002, Australia

Location

Local Institution

Parville, Victoria, 3050, Australia

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Hamilton, Ontario, L8V 5C2, Canada

Location

Local Institution

Seoul, 138-736, South Korea

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BMS 754807PaclitaxelBMS 181339Carboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

AU(2)KR(1)CA(2)