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A Phase 2 Open Label Extension Study of Conatumumab and AMG 479


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors, Carcinoid, Colorectal Cancer, Locally Advanced, Lymphoma, Metastatic Cancer, Non-Small Cell Lung Cancer, Sarcoma, Solid Tumors

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Trial Information

A Phase 2 Open Label Extension Study of Conatumumab and AMG 479


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety profile, including adverse events and serious adverse events, of conatumumab, with or without co-therapy, or AMG 479.

Outcome Time Frame:

Two to three years

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Poland: Ministry of Health

Study ID:

20101116

NCT ID:

NCT01327612

Start Date:

March 2011

Completion Date:

May 2013

Related Keywords:

  • Advanced Solid Tumors
  • Carcinoid
  • Colorectal Cancer
  • Locally Advanced
  • Lymphoma
  • Metastatic Cancer
  • Non-Small Cell Lung Cancer
  • Sarcoma
  • Solid Tumors
  • AMG 655
  • AMG 479
  • Apoptosis
  • Monoclonal Antibody
  • Tumor Necrosis Factor
  • Insulin-like Growth Factor
  • Bevacizumab
  • Modified FOLFOX6
  • mFOLFOX6
  • FOLFOX
  • Lymphoma
  • Trail Receptor
  • ganitumab
  • conatumumab
  • Carcinoid Tumor
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Lymphoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Sarcoma

Name

Location

Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Boca Raton, Florida  
Research Site Albany, New York  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah