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

Amgen12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors Carcinoid Colorectal Cancer Locally Advanced Lymphoma Metastatic Cancer

Interventions

Modified FOLFOX6DRUG

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.

ConatumumabBIOLOGICAL

Administered by intravenous infusion Q2W or Q3W.

GanitumabBIOLOGICAL

Administered by intravenous infusion Q3W or Q4W.

BevacizumabBIOLOGICAL

Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

Duarte, California, United States

Research Site

La Jolla, California, United States

Research Site

Denver, Colorado, United States

Research Site

Tampa, Florida, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Buffalo, New York, United States

Research Site

Memphis, Tennessee, United States

Research Site

Houston, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Ogden, Utah, United States

...and 2 more locations

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

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.

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.

Number of Participants With Serious Adverse Events

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.

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

Maximum Change From Baseline in Blood Pressure

Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.

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.

Minimum Change From Baseline in Blood Pressure

Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.

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

Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

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.

Best Overall Response

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.

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.

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.