Advanced Solid TumorsPhase 2NCT01327612
Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
A Phase 2 study testing Modified FOLFOX6, Conatumumab and Ganitumab in people with Advanced Solid Tumors and Carcinoid, run by Amgen at 12 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Carcinoid, Colorectal Cancer
- What is being tested?
- Modified FOLFOX6, Conatumumab and Ganitumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 3 Mar 2011to 5 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Buffalo, New York, 14263
Research Site
Denver, Colorado, 80218
Research Site
Duarte, California, 91010
Research Site
Houston, Texas, 77030
Research Site
La Jolla, California, 92093-0957
Research Site
Memphis, Tennessee, 38120
Research Site
Ogden, Utah, 84403
Research Site
San Antonio, Texas, 78229
Research Site
Tampa, Florida, 33612
About this study
Official title: A Phase 2 Open Label Extension Study of Conatumumab and AMG 479
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
- Being tested
- Modified FOLFOX6, Conatumumab, Ganitumab, Bevacizumab
- 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
- Medical subject headings
- Carcinoid Tumor, Colorectal Neoplasms, Lymphoma, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified FOLFOX6Drug
Also called Oxaliplatin-Leucovorin-Fluorouracil chemotherapy
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
Also called AMG 655
Administered by intravenous infusion Q2W or Q3W.
GanitumabBiological
Also called AMG 479
Administered by intravenous infusion Q3W or Q4W.
BevacizumabBiological
Also called Avastin
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Modified FOLFOX6; Biological: Conatumumab; Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
Measured: 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.
Measured: 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
Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study start3 Mar 2011
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327612
- Sponsor's protocol ID
- 20101116
- Other IDs
- 2010-022270-14
- Status last verified
- Feb 2021
- First submitted
- 3 Mar 2011
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Extension Study of Conatumumab and AMG 479
- ClinicalTrials.gov ID
- NCT01327612
- Acronym / sponsor ID
- 20101116
- Conditions
- Advanced Solid Tumors, Carcinoid, Colorectal Cancer, Locally Advanced, Lymphoma, Metastatic Cancer
- Keywords
- AMG 655, AMG 479, Apoptosis, Monoclonal Antibody, Tumor Necrosis Factor, Insulin-like Growth Factor, Bevacizumab, Modified FOLFOX6
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2011 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conatumumab Monotherapy | Experimental | Biological: ConatumumabParticipants 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 | Experimental | Biological: Conatumumab, Biological: GanitumabParticipants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study. |
| Ganitumab Monotherapy | Experimental | Biological: GanitumabParticipants 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 + mFOLFOX6 ± Bevacizumab | Experimental | Drug: Modified FOLFOX6, Biological: Conatumumab, Biological: BevacizumabParticipants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified FOLFOX6Also: Oxaliplatin-Leucovorin-Fluorouracil chemotherapyThe 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. | Drug | Conatumumab + mFOLFOX6 ± Bevacizumab |
| ConatumumabAlso: AMG 655Administered by intravenous infusion Q2W or Q3W. | Biological | Conatumumab + Ganitumab, Conatumumab + mFOLFOX6 ± Bevacizumab, Conatumumab Monotherapy |
| GanitumabAlso: AMG 479Administered by intravenous infusion Q3W or Q4W. | Biological | Conatumumab + Ganitumab, Ganitumab Monotherapy |
| BevacizumabAlso: AvastinAdministered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle. | Biological | Conatumumab + mFOLFOX6 ± Bevacizumab |
Primary outcome
Number of Participants With Adverse Events
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.
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
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.
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.
5 secondary outcomes
Maximum Change From Baseline in Blood Pressure
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
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.
Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modified FOLFOX6, Conatumumab and Ganitumab in people with Advanced Solid Tumors and Carcinoid, run by Amgen at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.