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Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors


Escalation Phase Subjects: Primary solid tumor not curable by local measures such as
surgery, radiation

Inclusion Criteria:



- Men and women age ≥ 18

Exclusion:

- More than 2 prior chemotherapy containing regimens for metastatic disease

- No prior exposure to cisplatin or ixabepilone

Expansion Phase Subjects: Advanced Non-small cell lung cancer

Inclusion Criteria:



- Men and women age ≥ 18

Exclusion:

- No prior chemotherapy-containing regimen for metastatic disease

- No prior exposure to cisplatin or ixabepilone

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Participants Experiencing Dose Limiting Toxicity (DLT)

Outcome Description:

DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.

Outcome Time Frame:

Within the first 21 days of first cycle

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-177

NCT ID:

NCT00832117

Start Date:

May 2009

Completion Date:

January 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Georgetown University Medical Center Washington, District of Columbia  20007
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033