Recent Updates
Recently added Catalysts

Conatumumab

Phase 2

Advanced Solid Tumors | Monoclonal antibody | Oncology |Amgen Inc.|Last Updated: Feb 21, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Conatumumab · 1 trial · 9 indications

Phase 2 1
NCT01327612Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)Advanced Solid Tumors
COMPLETED12 Analytics
PHASE2COMPLETED
Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events
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.

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.

Number of Participants With Serious Adverse Events
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.

A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.

Secondary Endpoints

Maximum Change From Baseline in Blood Pressure
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.
Minimum Change From Baseline in Blood Pressure
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.
Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
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.
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Conatumumab MonotherapyEXPERIMENTALParticipants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study.
Conatumumab + GanitumabEXPERIMENTALParticipants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.
Ganitumab MonotherapyEXPERIMENTALParticipants will continue to receive ganitumab Q3W or every 4 weeks (Q4W) at the same dose and regimen as at the conclusion of the parent study.
Conatumumab + mFOLFOX6 ± BevacizumabEXPERIMENTALParticipants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.

Interventions

NameTypeDescription
Modified FOLFOX6DRUGThe mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.
ConatumumabBIOLOGICALAdministered by intravenous infusion Q2W or Q3W.
GanitumabBIOLOGICALAdministered by intravenous infusion Q3W or Q4W.
BevacizumabBIOLOGICALAdministered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

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 hav...

Countries:United StatesPolandSpain
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")