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

Amgen

Status and phase: Completed; Phase 2

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

Treatments: Biological: Bevacizumab; Biological: Conatumumab; Drug: Modified FOLFOX6; Biological: Ganitumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01327612

20101116

2010-022270-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Conatumumab Monotherapy

Experimental group

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.

Treatment:

Biological: Conatumumab

Conatumumab + Ganitumab

Experimental group

Description:

Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.

Treatment:

Biological: Ganitumab

Biological: Conatumumab

Ganitumab Monotherapy

Experimental group

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.

Treatment:

Biological: Ganitumab

Conatumumab + mFOLFOX6 ± Bevacizumab

Experimental group

Description:

Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.

Treatment:

Biological: Conatumumab

Drug: Modified FOLFOX6

Biological: Bevacizumab