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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
History of Changes
  Purpose

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 Intervention Phase
Cancer
 Drug: BMS-833923 (XL139)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01413906     History of Changes
Other Study ID Numbers: CA194-010
Study First Received: August 4, 2011
Last Updated: May 31, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on June 18, 2013