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

Phase 2

Completed

Conditions: Carcinoid
Sarcoma
Solid Tumors
Lymphoma
Colorectal Cancer
Metastatic Cancer
Advanced Solid Tumors
Locally Advanced
Non-Small Cell Lung Cancer

Interventions: Biological: Ganitumab
Biological: Conatumumab
Drug: Modified FOLFOX6
Biological: Bevacizumab

Registration Number: NCT01327612

Lead Sponsor: Amgen

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ganitumab Monotherapy	Ganitumab	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.
Conatumumab Monotherapy	Conatumumab	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.
Conatumumab + Ganitumab	Ganitumab	Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.
Conatumumab + mFOLFOX6 ± Bevacizumab	Modified FOLFOX6	Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.
Conatumumab + Ganitumab	Conatumumab	Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.
Conatumumab + mFOLFOX6 ± Bevacizumab	Conatumumab	Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.
Conatumumab + mFOLFOX6 ± Bevacizumab	Bevacizumab	Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.	Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Best Overall Response	Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.	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.
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.	Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
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.	Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.
Number of Participants With Disease Progression or Death Due to Disease Progression	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.