A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Cell Genesys

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer; Nonresectable Pancreatic Cancer

Treatments: Biological: CG 8020 and CG 2505

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245362

P-0011

Details and patient eligibility

About

To evaluate the safety and effectiveness of CG8020 and CG2505.

Full description

To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
• Chemotherapy naïve or chemotherapy experienced pancreatic cancer

Exclusion criteria

• Prior cancer vaccines or gene therapy
• History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
• History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)