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

Phase 1

• Conditions: metastatic pancreatic cancer

• Registration Number: EUCTR2004-004243-21-GB
• Lead Sponsor: PDL BioPharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Males and females of at least 18 years of age with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who may have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies;

2. Measurable disease according to Response Criteria for Solid Tumors (RECIST);

3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1;

4. Negative pregnancy test (women of child-bearing potential only);

5. Pre-treatment laboratory levels that meet specific criteria;

6. Signed informed consent, including permission to use protected health information.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment with volociximab (M200) or alpha5beta1 integrin inhibitors (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens;

2. Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product; use of any IMP within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer);

3. Monoclonal antibody therapy within 4 weeks of volociximab (M200) administration;

4. Documented CNS tumor or CNS metastasis;

5. History of thromboembolic events and bleeding disorders within the past year;

6. Medical conditions that may be exacerbated by bleeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified