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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01413906
First received: August 4, 2011
Last updated: May 31, 2013
Last verified: May 2013

August 4, 2011
May 31, 2013
November 2011
November 2012   (final data collection date for primary outcome measure)
  • Incidence of Dose Limiting Toxicity (DLT) and observed adverse events [ Time Frame: Within the first 28 days of treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01413906 on ClinicalTrials.gov Archive Site
  • The number of subjects experienced DLT [ Time Frame: Within the first 28 days ] [ Designated as safety issue: Yes ]
  • Maximum observed concentration (Cmax) of BMS-833923 (XL139) [ Time Frame: Day1 and Day 29 ] [ Designated as safety issue: No ]
  • Trough observed concentration (Cmin) of BMS-833923 (XL139) [ Time Frame: Day1 and Day 29 ] [ Designated as safety issue: No ]
  • Time of maximum observed concentration (Tmax) of BMS-833923 (XL139) [ Time Frame: Day1 and Day 29 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139) [ Time Frame: Day1 and Day 29 ] [ Designated as safety issue: No ]
  • Effective half-life (T-half,eff) of BMS-833923 (XL139) [ Time Frame: Day1 and Day 29 ] [ Designated as safety issue: No ]
  • Accumulation index (AI) of BMS-833923 (XL139) [ Time Frame: Day1 and Day 29 ] [ Designated as safety issue: No ]
  • Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria [ Time Frame: Up to120 days of treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
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)
Experimental: Arm 1: BMS-833923 (XL139)
Intervention: Drug: BMS-833923 (XL139)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01413906
CA194-010
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP