Pancreatic Cancer Clinical Trial
Official title:
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer
This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.
| Status | Completed |
| Enrollment | 138 |
| Est. completion date | April 2012 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV) - Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery. Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence. - Men or women = 18 years of age - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - Adequate hematologic, hepatic, renal and coagulation function - Amylase and lipase = 2.0 x ULN - Adequately controlled type 1 or 2 diabetic subjects Exclusion Criteria: - Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma - Known central nervous system metastases - Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity - Adjuvant chemotherapy or chemoradiotherapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albany | New York |
| United States | Research Site | Alhambra | California |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Eugene | Oregon |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Harvey | Illinois |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Miami | Florida |
| United States | Research Site | New York | New York |
| United States | Research Site | Northridge | California |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Oxnard | California |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Redondo Beach | California |
| United States | Research Site | Round Rock | Texas |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Santa Maria | California |
| United States | Research Site | Santa Monica | California |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tyler | Texas |
| United States | Research Site | Westminster | Maryland |
| United States | Research Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| NantCell, Inc. |
United States,
Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. — View Citation
Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-42. doi: 10.1093/annonc/mds142. — View Citation
Lu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;
McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. — View Citation
TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | 6 months | No | |
| Primary | Safety | Length of the study | No | |
| Secondary | Safety and Efficacy Endpoints | Length of the study | No | |
| Secondary | Overall Survival | Length of the study | No | |
| Secondary | Time to Response | Length of the study | No |
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