Clinical trial NCT01327612: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
Official title: A Phase 2 Open Label Extension Study of Conatumumab and AMG 479
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Solid Tumors
Carcinoid
Colorectal Cancer
Locally Advanced
Lymphoma
Metastatic Cancer
Non-Small Cell Lung Cancer
Sarcoma
Solid Tumors
Keywords: AMG 655
AMG 479
Apoptosis
Monoclonal Antibody
Tumor Necrosis Factor
Insulin-like Growth Factor
Bevacizumab
Modified FOLFOX6
mFOLFOX6
FOLFOX
Lymphoma
Trail Receptor
ganitumab
conatumumab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to allow continued treatment with conatumumab and/or ganitumab, with or without chemotherapy, to participants who completed a separate Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous studies were closed.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
measure: Number of Participants With Serious Adverse Events
timeFrame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Secondary outcomes:
measure: Maximum Change From Baseline in Blood Pressure
timeFrame: Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
measure: Minimum Change From Baseline in Blood Pressure
timeFrame: Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
measure: Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
timeFrame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
measure: Best Overall Response
timeFrame: Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
measure: Number of Participants With Disease Progression or Death Due to Disease Progression
timeFrame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Szczecin
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: