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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413906
• Other study ID #: CA194-010
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2011
• Last updated: May 31, 2013
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Japan	Local Institution	Kashiwa-shi	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose Limiting Toxicity (DLT) and observed adverse events		Within the first 28 days of treatment	Yes
Primary	Incidence of Dose Limiting Toxicity (DLT) and observed adverse events		Up to 90 days additional treatment period plus 60 days of follow-up	Yes
Secondary	The number of subjects experienced DLT		Within the first 28 days	Yes
Secondary	Maximum observed concentration (Cmax) of BMS-833923 (XL139)		Day1 and Day 29	No
Secondary	Trough observed concentration (Cmin) of BMS-833923 (XL139)		Day1 and Day 29	No
Secondary	Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)		Day1 and Day 29	No
Secondary	Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)		Day1 and Day 29	No
Secondary	Effective half-life (T-half,eff) of BMS-833923 (XL139)		Day1 and Day 29	No
Secondary	Accumulation index (AI) of BMS-833923 (XL139)		Day1 and Day 29	No
Secondary	Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria		Up to120 days of treatment period	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form