Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

Adenocarcinoma of the Pancreas Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01318642
• Other study ID #: 20080261
• Secondary ID: 2010-023978-39
• Status: Terminated
• Phase: Phase 2
• First received: March 17, 2011
• Last updated: August 6, 2014
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationUnited States: Schulman Associates IRB
• Study type: Interventional

Clinical Trial Summary

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Description:

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice

• Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1

• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

• Men or women >/= 18 years of age

• Adequate organ function

Exclusion Criteria:

• Early (stage I) or metastatic (stage IV) disease

• Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma

• External biliary drain

• Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer

• Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Pancreas
• Locally Advanced
• Unresectable

Intervention

Drug:
• Gemcitabine
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
• AMG 479
Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
• Placebo
Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle

Locations

Country	Name	City	State
Austria	Research Site	Salzburg
Austria	Research Site	Steyer
Austria	Research Site	Wien
Belgium	Research Site	Edegem
Belgium	Research Site	Haine St. Paul - La Louviere
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 10
Denmark	Research Site	Herlev
Germany	Research Site	Hamburg
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Miskolc
Hungary	Research Site	Szolnok
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Poland	Research Site	Lodz
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Samara
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Madrid
United Kingdom	Research Site	Guys Hospital
United Kingdom	Research Site	London
United Kingdom	Research Site	Preston
United States	Research Site	Knoxville	Tennessee
United States	Research Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czech Republic,  Denmark,  Germany,  Hungary,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is progression-free survival (PFS) as defined as the time from randomization to progression (per RECIST v1.1) or death.		Approximately 23 months	No
Secondary	Progression-free survival and overall survival rates at 3, 6, 9, 12, 18, and 24 months		Approximately 23 months	No
Secondary	Objective response rate (complete or partial response) per RECIST v1.1		Approximately 23 months	No
Secondary	Overall survival		Approximately 23 months	No

External Links

•   AmgenTrials clinical trials website