NCT00329004

Brief Summary

The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Aug 2006

Geographic Reach
4 countries

7 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 19, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 25, 2011

Status Verified

August 1, 2009

Enrollment Period

2.9 years

First QC Date

May 19, 2006

Last Update Submit

January 24, 2011

Conditions

CancerTumor

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Safety

    results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks

  • Highest dose tolerated

    continuous medical review of adverse event reports

Secondary Outcomes (1)

  • Effective dose or doses of BMS-690514

    tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports

Study Arms (1)

1

EXPERIMENTAL
Drug: BMS-690514

Interventions

BMS-690514DRUG

Tablets, Oral, up to 300 mg, once daily, up to 24 mos

Also known as: panHER
1

Eligibility Criteria

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

You may qualify if:

  • Men and women 18 and older
  • Diagnosis of any solid tumor
  • ECOG performance status score 0-1
  • Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
  • Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

You may not qualify if:

  • Treatment with other TKIs within the past 4 weeks
  • Patients with brain metastasis
  • Patients with centrally located squamous cell carcinoma of the lung
  • Major gastrointestinal surgery which may affect absorption of the drug
  • Any surgery within last 4 weeks
  • History of thromboembolism
  • Severe unmanageable diarrhea
  • Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
  • Part B/Cohort I erlotinib-naive subjects
  • Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Indiana University Med Center

Indianapolis, Indiana, 46202, United States

Location

The University Of Texas Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Toulouse, 31052, France

Location

Local Institution

Villejuif, 94805, France

Location

Local Institution

Barcelona, 08035, Spain

Location

Related Publications (1)

  • Soria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13.

    PMID: 23490650DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-690514

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 19, 2006

First Posted

May 24, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 25, 2011

Record last verified: 2009-08

Locations

ES(1)CA(2)FR(2)US(2)