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

Colorectal Cancer Clinical Trial

Official title:

A Phase 2 Open Label Extension Study of Conatumumab and AMG 479

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327612
• Other study ID #: 20101116
• Secondary ID: 2010-022270-14
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2011
• Est. completion date: February 5, 2020

Study information

• Verified date: February 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Carcinoid
• Carcinoid Tumor
• Colorectal Cancer
• Locally Advanced
• Lymphoma
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Non-Small Cell Lung Cancer
• Sarcoma
• Solid Tumors

Intervention

Drug:
• Modified FOLFOX6
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.

Biological:
• Conatumumab
Administered by intravenous infusion Q2W or Q3W.
• Ganitumab
Administered by intravenous infusion Q3W or Q4W.
• Bevacizumab
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.

Locations

Country	Name	City	State
Poland	Research Site	Szczecin
Spain	Research Site	Barcelona	Cataluña
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Buffalo	New York
United States	Research Site	Denver	Colorado
United States	Research Site	Duarte	California
United States	Research Site	Houston	Texas
United States	Research Site	La Jolla	California
United States	Research Site	Memphis	Tennessee
United States	Research Site	Ogden	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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	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.	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.
Secondary	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.	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.
Secondary	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.	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	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.	Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Secondary	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.

External Links

•   AmgenTrials clinical trials website