Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

NCT ID: NCT01413906

Last Updated: 2013-06-03

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.

Detailed Description

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Conditions

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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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Arm 1: BMS-833923 (XL139)

Group Type EXPERIMENTAL

BMS-833923 (XL139)

Intervention Type DRUG

Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria

Interventions

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BMS-833923 (XL139)

Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria

Intervention Type DRUG

Other Intervention Names

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(XL139)

Eligibility Criteria

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Inclusion Criteria

* Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
* Men and woman, 20 years of age and above

Exclusion Criteria

* Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
* Inability to swallow oral medication
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow function
* Inadequate hepatic function
* Inadequate renal function
* Pancreatitis
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Kashiwa-shi, Chiba, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA194-010

Identifier Type: -

Identifier Source: org_study_id