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A Phase 1 Study Of CP- 870,893 In Combination With Paclitaxel And Carboplatin In Patients With Metastatic Solid Tumors


Phase 1
18 Years
85 Years
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase 1 Study Of CP- 870,893 In Combination With Paclitaxel And Carboplatin In Patients With Metastatic Solid Tumors


Inclusion Criteria:



- Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are
appropriate;

- Patients >18 years of age;

- Good performance status;

- Adequate bone marrow and organ function

Exclusion Criteria:

- Previous treatment with any other compound that targets CD40

- Current or planned concurrent treatment with any anticancer agent;

- Patients who have received bone marrow transplant;

- History of autoimmune disorder

- History (within the previous year) of heart failure or heart attack

- Cancer-associated coagulation disorders

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)

Outcome Description:

Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2.

Outcome Time Frame:

Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A5021004

NCT ID:

NCT00607048

Start Date:

November 2007

Completion Date:

July 2009

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535