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Mass Balance, Pharmacokinetics and Metabolism of [14C]BMS-582664 Prodrug of BMS-540215, in Subjects With Advanced or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

Mass Balance, Pharmacokinetics and Metabolism of [14C]BMS-582664 Prodrug of BMS-540215, in Subjects With Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- Histologic/cytologic diagnosis of advanced or metastatic solid tumors

- ECOG 0-2

- 4/6 weeks since prior therapy

Exclusion Criteria:

- Brain metastases

- Secondary primary malignancy

- Thromboembolic disease requiring full anticoagulation within 6 months

- Inability to swallow or absorb oral therapy

- Uncontrolled hypertension

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Absorption

Outcome Time Frame:

Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA182-008

NCT ID:

NCT00435669

Start Date:

September 2007

Completion Date:

June 2008

Related Keywords:

  • Tumors
  • Advanced or metastatic solid tumors

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195