A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

NCT ID: NCT00670189

Last Updated: 2014-08-15

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule

Detailed Description

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Conditions

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Hedgehog Pathway Smoothened Basal Cell Carcinoma (BCC) Basal Cell Nevoid Syndrome (BCNS)

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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BMS-833923

Group Type EXPERIMENTAL

BMS-833923 (XL139)

Intervention Type DRUG

Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

Interventions

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BMS-833923 (XL139)

Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma
* Primary or metastatic tumor site accessible for biopsy
* Ability to swallow capsules
* Subjects with histologically confirmed, advanced stage IIIB or stage IV non-small cell lung cancer (NSCLC) with a primary histology of squamous carcinoma who have received prior systemic therapy for advanced NSCLC will be enrolled in Part 3

Exclusion Criteria

* Uncontrolled brain metastasis
* Significant cardiovascular disease
* Inadequate blood counts
* Inadequate liver, kidney or lung function
* Gastrointestinal disease within last 3 months
* Infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or exposure to attenuated active immunizations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exelixis

INDUSTRY

Sponsor Role collaborator

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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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Southwest Texas Addiction Research And Tech (Start) Center

San Antonio, Texas, United States

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

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Other Identifiers

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CA194-002

Identifier Type: -

Identifier Source: org_study_id

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