Open Label Extension Study of Conatumumab and AMG 479

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01327612
First received: March 3, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The purpose of this protocol is to allow continued treatment with conatumumab and/or AMG 479, with or without chemotherapy to subjects without disease progression whose previous studies were closed.


Condition Intervention Phase
Advanced Solid Tumors
Carcinoid
Colorectal Cancer
Locally Advanced
Lymphoma
Metastatic Cancer
Non-Small Cell Lung Cancer
Sarcoma
Solid Tumors
Drug: FOLFOX6
Biological: Conatumumab
Biological: Ganitumab
Biological: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Extension Study of Conatumumab and AMG 479

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To evaluate the safety profile, including adverse events and serious adverse events, of conatumumab, with or without co-therapy, or AMG 479. [ Time Frame: Two to three years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Treatment
Combination treatment: Conatumumab Q2W or Q3W + ongoing chemotherapy or ganitumab.
Drug: FOLFOX6
Oxaliplatin: 100mg/m2, IV in 500mL of D5W over 120 minutes on Day 1 Leucovorin: 400mg/m2, IV diluted in D5W over 120 minutes (concurrently with oxaliplatin) on Day 1 Fluorouracil: 400 mg/m2, IV bolus, after leucovorin, on Day 1 Fluorouracil: 2400mg/m2, CIV over 46 hours (single dose) start on Day 1 Cycle frequency: repeat every 14 days until disease progression or unacceptable toxicity
Other Name: Oxaliplatin-Leucovorin-Fluorouracil chemotherapy
Biological: Conatumumab
Conatumumab is an investigational, fully human monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR-5.
Other Name: AMG 655
Biological: Ganitumab
Ganitumab is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
Other Name: AMG 479
Biological: Bevacizumab
Recombinant humanized monoclonal antibody targeted against vascular endothelial growth factor (VEGF); angiogenesis inhibitor.
Other Name: Avastin
Experimental: Monotherapy Treatment
Monotherapy treatment: Conatumumab Q2W or Q3W; or AMG 479 Q3W or Q4W
Biological: Conatumumab
Conatumumab is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR5.
Other Name: AMG 655
Biological: Ganitumab
Ganitumab is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
Other Name: AMG 479

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone.

Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol

Exclusion Criteria:

  • Discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab
  • Subjects determined to have disease progression during their participation in the parent Amgen study
  • Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration
  • Subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration
  • Male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration
  • Subject has previously entered this study
  • Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327612

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, California
Research Site Completed
Duarte, California, United States, 91010
Research Site Completed
La Jolla, California, United States, 92093-0957
United States, Colorado
Research Site Completed
Denver, Colorado, United States, 80218
United States, Florida
Research Site Recruiting
Tampa, Florida, United States, 33612
United States, New York
Research Site Recruiting
Buffalo, New York, United States, 14263
United States, Tennessee
Research Site Recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site Recruiting
Ogden, Utah, United States, 84403
Poland
Research Site Recruiting
Szczecin, Poland, 70-891
Spain
Research Site Recruiting
Barcelona, Cataluña, Spain, 08035
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01327612     History of Changes
Other Study ID Numbers: 20101116
Study First Received: March 3, 2011
Last Updated: February 12, 2014
Health Authority: Poland: Ministry of Health
Spain: Spanish Agency of Medicines
United States: Western Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Amgen:
AMG 655
AMG 479
Apoptosis
Monoclonal Antibody
Tumor Necrosis Factor
Insulin-like Growth Factor
Bevacizumab
Modified FOLFOX6
mFOLFOX6
FOLFOX
Lymphoma
Trail Receptor
ganitumab
conatumumab

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Lymphoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on July 26, 2014