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

NCT01327612 | Completed Phase 2 Results

• 2 other identifiers: 201011162010-022270-14
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 12

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.

Conditions

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

Keywords

AMG 655; AMG 479; Apoptosis; Monoclonal Antibody; Tumor Necrosis Factor; Insulin-like Growth Factor; Bevacizumab; Modified FOLFOX6; mFOLFOX6; FOLFOX; Lymphoma; Trail Receptor; ganitumab; conatumumab

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

Conatumumab Monotherapy

EXPERIMENTAL

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.

Biological: Conatumumab

Conatumumab + Ganitumab

EXPERIMENTAL

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

Biological: Conatumumab; Biological: Ganitumab

Ganitumab Monotherapy

EXPERIMENTAL

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.

Biological: Ganitumab

Conatumumab + mFOLFOX6 ± Bevacizumab

EXPERIMENTAL

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

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

Interventions

Modified FOLFOX6 DRUG

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.

Also known as: Oxaliplatin-Leucovorin-Fluorouracil chemotherapy

Conatumumab + mFOLFOX6 ± Bevacizumab

Conatumumab BIOLOGICAL

Administered by intravenous infusion Q2W or Q3W.

Also known as: AMG 655

Conatumumab + Ganitumab; Conatumumab + mFOLFOX6 ± Bevacizumab; Conatumumab Monotherapy

Ganitumab BIOLOGICAL

Administered by intravenous infusion Q3W or Q4W.

Also known as: AMG 479

Conatumumab + Ganitumab; Ganitumab Monotherapy

Bevacizumab BIOLOGICAL

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

Also known as: Avastin

Conatumumab + mFOLFOX6 ± Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (12)

Research Site

Duarte, California, 91010, United States

Location

Research Site

La Jolla, California, 92093-0957, United States

Location

Research Site

Denver, Colorado, 80218, United States

Location

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Buffalo, New York, 14263, United States

Location

Research Site

Memphis, Tennessee, 38120, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Ogden, Utah, 84403, United States

Location

Research Site

Szczecin, 70-891, Poland

Location

Research Site

Barcelona, Catalonia, 08035, Spain

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoid Tumor; Colorectal Neoplasms; Lymphoma; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Sarcoma

Interventions

conatumumab; ganitumab; Bevacizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: April 1, 2011
• Study Start: March 3, 2011
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

ES (1); US (10); PL (1)