Open Label Extension Study of Conatumumab and AMG 479

This study is currently recruiting participants.
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

March 3, 2011
February 12, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
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 ]
: To evaluate the safety profile of conatumumab, with or without chemotherapy (including bevacizumab) or ganitumab, by measuring adverse events/serious adverse events. [ Time Frame: Two to three years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01327612 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Open Label Extension Study of Conatumumab and AMG 479
A Phase 2 Open Label Extension Study of Conatumumab and AMG 479

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Carcinoid
  • Colorectal Cancer
  • Locally Advanced
  • Lymphoma
  • Metastatic Cancer
  • Non-Small Cell Lung Cancer
  • Sarcoma
  • Solid Tumors
  • 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: 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
  • Biological: Bevacizumab
    Recombinant humanized monoclonal antibody targeted against vascular endothelial growth factor (VEGF); angiogenesis inhibitor.
    Other Name: Avastin
  • Experimental: Combination Treatment
    Combination treatment: Conatumumab Q2W or Q3W + ongoing chemotherapy or ganitumab.
    Interventions:
    • Drug: FOLFOX6
    • Biological: Conatumumab
    • Biological: Ganitumab
    • Biological: Bevacizumab
  • Experimental: Monotherapy Treatment
    Monotherapy treatment: Conatumumab Q2W or Q3W; or AMG 479 Q3W or Q4W
    Interventions:
    • Biological: Conatumumab
    • Biological: Ganitumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Amgen Call Center 866-572-6436
United States,   Poland,   Spain
 
NCT01327612
20101116
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2014

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