A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

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Detailed Description

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Conditions

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Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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BMS-275183

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-hematologic malignancy that has progressed or no standard therapy is known
* Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* No more than 3 prior chemotherapy regimens in advanced/metastatic setting
* Absolute neutrophil count \>=1,500/mm3 and platelets \>=100,000/mm3
* Bilirubin \<=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase \<=2.5 x ULN
* Serum creatinine \<=1.5 x ULN
* Men and women \>=18 years
* Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study

Exclusion Criteria

* WOCBP and men not using adequate method of birth control
* WOCBP who are pregnant or breastfeeding
* Prior radiation \>=25% of bone marrow containing skeleton
* Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
* Neuropathy
* Active brain metastases
* Inability to swallow capsules
* History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube
* Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No