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

May 31, 2013 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: BMS-833923 (XL139)
Drug: 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
Other Names:
  • (XL139)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Time Frame: Within the first 28 days of treatment
Within the first 28 days of treatment
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Time Frame: Up to 90 days additional treatment period plus 60 days of follow-up
Up to 90 days additional treatment period plus 60 days of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of subjects experienced DLT
Time Frame: Within the first 28 days
Within the first 28 days
Maximum observed concentration (Cmax) of BMS-833923 (XL139)
Time Frame: Day1 and Day 29
Day1 and Day 29
Trough observed concentration (Cmin) of BMS-833923 (XL139)
Time Frame: Day1 and Day 29
Day1 and Day 29
Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)
Time Frame: Day1 and Day 29
Day1 and Day 29
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)
Time Frame: Day1 and Day 29
Day1 and Day 29
Effective half-life (T-half,eff) of BMS-833923 (XL139)
Time Frame: Day1 and Day 29
Day1 and Day 29
Accumulation index (AI) of BMS-833923 (XL139)
Time Frame: Day1 and Day 29
Day1 and Day 29
Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria
Time Frame: Up to120 days of treatment period
Up to120 days of treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CA194-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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