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

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ClinicalTrials.gov Identifier: NCT01413906
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: BMS-833923 (XL139) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
Study Start Date : November 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012
Arms and Interventions

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 Name: (XL139)


Outcome Measures

Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicity (DLT) and observed adverse events [ Time Frame: Within the first 28 days of treatment ]
  2. 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 ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413906


Locations
Japan
Local Institution
Kashiwa-shi, Chiba, Japan, 2778577
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01413906     History of Changes
Other Study ID Numbers: CA194-010
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013