NCT01327612 · REGISTRY CONDITION SEARCH

Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-02-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

Number of Participants With Serious Adverse Events

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outcome · POSTED

Maximum Change From Baseline in Blood Pressure

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outcome · POSTED

Minimum Change From Baseline in Blood Pressure

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outcome · POSTED

Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities

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outcome · POSTED

Best Overall Response

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outcome · POSTED

Number of Participants With Disease Progression or Death Due to Disease Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants 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.
intervention Names
Biological: Conatumumab
label
Conatumumab Monotherapy
type
EXPERIMENTAL
description
Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.
intervention Names
Biological: Conatumumab
Biological: Ganitumab
label
Conatumumab + Ganitumab
type
EXPERIMENTAL
description
Participants 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.
intervention Names
Biological: Ganitumab
label
Ganitumab Monotherapy
type
EXPERIMENTAL
description
Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.
intervention Names
Drug: Modified FOLFOX6
Biological: Conatumumab
Biological: Bevacizumab
label
Conatumumab + mFOLFOX6 ± Bevacizumab
type
EXPERIMENTAL

interventions

arm Group Labels
Conatumumab + mFOLFOX6 ± Bevacizumab
description
The 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.
name
Modified FOLFOX6
other Names
Oxaliplatin-Leucovorin-Fluorouracil chemotherapy
type
DRUG
arm Group Labels
Conatumumab + Ganitumab
Conatumumab + mFOLFOX6 ± Bevacizumab
Conatumumab Monotherapy
description
Administered by intravenous infusion Q2W or Q3W.
name
Conatumumab
other Names
AMG 655
type
BIOLOGICAL
arm Group Labels
Conatumumab + Ganitumab
Ganitumab Monotherapy
description
Administered by intravenous infusion Q3W or Q4W.
name
Ganitumab
other Names
AMG 479
type
BIOLOGICAL
arm Group Labels
Conatumumab + mFOLFOX6 ± Bevacizumab
description
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
name
Bevacizumab
other Names
Avastin
type
BIOLOGICAL

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Adverse Events
time Frame
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.
description
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.
measure
Number of Participants With Serious Adverse Events
time Frame
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

description
Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
measure
Maximum Change From Baseline in Blood Pressure
time Frame
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.
description
Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.
measure
Minimum Change From Baseline in Blood Pressure
time Frame
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.
description
Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
measure
Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
time Frame
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.
description
Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.
measure
Best Overall Response
time Frame
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
time Frame
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.

Full study description

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.

Source references