Expired Study
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Rancho Mirage, California 92270


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


Study is Available At:


Original ID:

20060323


NCT ID:

NCT00630552


Secondary ID:

QUILT-2.019


Study Acronym:


Brief Title:

QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer


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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NantCell, Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board
  • United States: Western Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

138


Enrollment Type:

Actual


Overall Contact Information

Official Name:MD
Study Director
Amgen

Study Dates

Start Date:June 2007
Completion Date:April 2012
Completion Type:Actual
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 26, 2016
First Received Date:February 28, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Survival
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety
Time Frame:Length of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety and Efficacy Endpoints
Time Frame:Length of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Length of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Response
Time Frame:Length of the study
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Placebo
Description:Inactive dummy of AMG 655.
Arm Name:Placebo + Gemcitabine
Intervention Type:Drug
Name:AMG 479
Description:AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
Arm Name:AMG 479 + Gemcitabine
Intervention Type:Drug
Name:AMG 655
Description:AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Arm Name:AMG 655 + Gemcitabine

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo + Gemcitabine
Study Arm Type:Experimental
Arm Name:AMG 655 + Gemcitabine
Study Arm Type:Experimental
Arm Name:AMG 479 + Gemcitabine

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:NantCell, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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. Epub 2012 Jun 8.
PMID:22678353
Reference Type:Reference
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. Epub 2012 Jun 13.
PMID:22700995
Reference Type:Reference
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;
Reference Type:Reference
Citation: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. Epub 2013 Jun 5.
PMID:23741071
Reference Type:Reference
Citation:TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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