Know Cancer

or
forgot password

A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasm

Thank you

Trial Information

A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer


Inclusion Criteria:



- 1st-line surgically incurable cancer of the pancreas

- ECOG(Eastern Cooperative Oncology Group) performance status 0-1

Exclusion Criteria:

- Previous systemic therapy for pancreas cancer

- History of cancer-associated blood clots

- History of autoimmune disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Dose Limiting Toxicities (DLTs)

Outcome Description:

Any of the following during first cycle of treatment and attributable to CP-870893: afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia).

Outcome Time Frame:

Baseline up to Cycle 1 / Day 28

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:

A5021005

NCT ID:

NCT00711191

Start Date:

June 2008

Completion Date:

January 2011

Related Keywords:

  • Pancreatic Neoplasm
  • pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535