A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

BMS-690514

Intervention Type DRUG

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

Interventions

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BMS-690514

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

Intervention Type DRUG

Other Intervention Names

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panHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No