NCT00479583

Brief Summary

The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Sep 2007

Geographic Reach
2 countries

4 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

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 30, 2011

Status Verified

March 1, 2011

Enrollment Period

2.6 years

First QC Date

May 24, 2007

Last Update Submit

November 29, 2011

Conditions

Cancer

Keywords

Cancer (solid tumors)

Outcome Measures

Primary Outcomes (3)

  • Safety assessment

    throughout the study

  • dose-limiting toxicity (DLT)

    assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified

  • determination of maximum tolerated dose (MTD)

    during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified

Secondary Outcomes (2)

  • Describe anti-tumor of combination therapy

    Every 8 weeks throughout the study

  • Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples

    throughtout the study

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: BMS-690514 / FOLFIRI

B

ACTIVE COMPARATOR
Drug: BMS-690514 / FOLFOX

Interventions

BMS-690514 / FOLFIRIDRUG

Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos

A
BMS-690514 / FOLFOXDRUG

Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos

B

Eligibility Criteria

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

You may qualify if:

  • Patients eligible for FOLFIRI or FOLFOX therapy
  • ECOG performance status score 0-1
  • At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
  • At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
  • No maximum age for Study Arm A (FOLFOX)
  • years of age for Study Arm B (FOLFIRI)

You may not qualify if:

  • Treatment with other TKIs within the past 4 weeks
  • Active inflammatory bowel disease
  • Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
  • History of thromboembolism
  • Severe unmanageable diarrhea
  • Uncontrolled or significant cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution

Saint-Herblain, 44805, France

Location

Local Institution

Villejuif, 94805, France

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-690514Folfox protocol

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

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 28, 2007

Study Start

September 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 30, 2011

Record last verified: 2011-03

Locations

US(2)FR(2)