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
  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:


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:
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 April 21, 2014