Expired Study
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Oxnard, California 93030


Purpose:

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.


Criteria:

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


NCT ID:

NCT00630552


Primary Contact:

Study Director
MD
Amgen


Backup Contact:

N/A


Location Contact:

Oxnard, California 93030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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