metastatic pancreatic cancer
Conditions
Interventions
Product Name: M200
Product Code: M200
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: volociximab
Current Sponsor code:
Sponsors
PDL BioPharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy (tumor response) of volociximab in combination with gemcitabine in patients with metastatic pancreatic cancer, as defined using Response Criteria for Solid Tumors (RECIST).; Secondary Objective: 1. Evaluate efficacy of volociximab using secondary efficacy measures. 2. Evaluate safety of volociximab in combination with gemcitabine. 3. Evaluate the pharmacokinetics (PK) of volociximab. 4. Evaluate immunogenicity of volociximab. ; Primary end point(s): The proportion of patients in each dose cohort with a confirmed tumor response at any time during the study. | — |
Countries
United Kingdom
Outcome results
None listed