A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-08-04

Brief Summary

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The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

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Detailed Description

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Conditions

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Advanced Solid Cancers Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cdc7-inhibitor

Group Type EXPERIMENTAL

Cdc7-inhibitor

Intervention Type DRUG

Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months

Interventions

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Cdc7-inhibitor

Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months

Intervention Type DRUG

Other Intervention Names

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BMS-863233 XL413

Eligibility Criteria

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Inclusion Criteria

* Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist.
* ECOG performance status ≤ 2
* Accessible for treatment, PK sample collection and required study follow-up
* Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
* Exposure to any investigational agent within 4 weeks of study drug administration
* Subjects a history of gastrointestinal disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No