Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

This study has been terminated.
(Due to a pre-planned Interim Analysis 20060540 study was stopped for futility with no safety concerns. 20080261 study has also been stopped as a result of this)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01318642
First received: March 17, 2011
Last updated: March 29, 2013
Last verified: March 2013

March 17, 2011
March 29, 2013
May 2012
November 2012   (final data collection date for primary outcome measure)
The primary endpoint is progression-free survival (PFS) as defined as the time from randomization to progression (per RECIST v1.1) or death. [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01318642 on ClinicalTrials.gov Archive Site
  • Progression-free survival and overall survival rates at 3, 6, 9, 12, 18, and 24 months [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]
  • Objective response rate (complete or partial response) per RECIST v1.1 [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Approximately 23 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Adenocarcinoma of the Pancreas
  • Locally Advanced
  • Unresectable
  • Drug: Gemcitabine
    gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
    Other Name: Gemzar
  • Drug: AMG 479 + gemcitabine
    gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
    Other Name: gemcitabine = Gemzar
  • Active Comparator: Placebo + Gemcitabine
    Intervention: Drug: Gemcitabine
  • Experimental: AMG 479 20 mg/kg + gemcitabine
    Intervention: Drug: AMG 479 + gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Czech Republic,   Denmark,   Germany,   Hungary,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Spain,   United Kingdom
 
NCT01318642
20080261, 2010-023978-39
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP