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Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy


Inclusion Criteria:



- Male or female, 18 years of age or older.

- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.

- May have received prior immunotherapy (including monoclonal antibodies) or vaccine
therapies.

- Measurable disease, according to RECIST criteria.

- Negative pregnancy test (women of childbearing potential only).

- Pretreatment laboratory levels that meet specific criteria.

Exclusion Criteria:

- Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or
small molecules) or gemcitabine and other chemotherapeutic regimens.

- Known hypersensitivity to murine proteins or chimeric antibodies or other components
of the product.

- Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of
the prior investigational drug (whichever is longer).

- Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab.

- Central Nervous System (CNS) tumor or metastasis.

- History of bleeding disorders within the past year.

- Medical conditions that may be exacerbated by bleeding.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients, in each dose cohort, with a confirmed tumor response

Outcome Time Frame:

Any time during the course of the trial (up to 104 weeks)

Safety Issue:

No

Principal Investigator

Mihail Obrocea, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M200-1205

NCT ID:

NCT00401570

Start Date:

March 2005

Completion Date:

June 2008

Related Keywords:

  • Pancreatic Cancer
  • Antibody
  • Pancreas
  • Carcinoma
  • Cancer
  • Pancreatic
  • Pancreatic Neoplasms

Name

Location

Site Reference ID/Investigator# 70538Pittsburgh, Pennsylvania  15213
Site Reference ID/Investigator# 70537Nashville, Tennessee  37232-7415