Advanced Solid TumorsPhase 1NCT01137552
A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumors
A Phase 1 study testing AMG 780 in people with Advanced Solid Tumors, run by Amgen at 3 sites in United States.
Trial summary
This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AMG 780
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men and women ≥ 18 years old
- Must have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy
- Measurable disease by RECIST criteria
- Must be able to undergo MRI evaluation
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Competent to sign and date an Institutional Review Board approved informed consent form
Who cannot join
- Presence of untreated or symptomatic primary central nervous system tumors or metastases
- Presence of leukemia or myelodysplastic syndrome
- Subjects with head and neck cancer
- Previous hematopoietic stem cell transplant (allogeneic)
- Unresolved hematological toxicities > grade 1 with the exception of grade 2 lymphopenia and non-hematological toxicities > grade 1, excluding alopecia and grade 2 neuropathy, from prior anti-cancer therapy
- Myocardial infarction within 1 year before study day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function
Show all 19Show fewer
- History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study
- Active peripheral vascular disease
- History of bleeding diathesis
- History of pulmonary hemorrhage or gross hemoptysis within 6 months before study
- Known history of adrenal hemorrhage
- Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C
- Major surgery within 1 month before study
- Prior treatment with any agent targeting the angiopoietin-Tie2 signaling pathway
- Concurrent antitumor treatment, except Lupron for subjects with prostate cancer and selective estrogen receptor modulators (SERMS) for subjects with breast cancer, within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1
- Known sensitivity to mammalian-derived products, bacterially-produced proteins, or any of the products to be administered during dosing
- Investigational agent within 30 days before study
- Pregnant (eg, positive urine test) or breastfeeding
- Subjects of childbearing potential, or subject who has a partner of childbearing potential, and is not using highly effective contraceptive precautions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Cleveland, Ohio, 44106
Research Site
Durham, North Carolina, 27710
Research Site
Los Angeles, California, 90048
About this study
Official title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 780 in Adult Subjects With Advanced Solid Tumors
This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
- Conditions
- Advanced Solid Tumors
- Being tested
- AMG 780
- Keywords
- First-In-Human, Dose Escalation, Dose Expansion, Advance Solid Tumors, Anti-Angiopoietin, Advance Malignancy, Cancer, Oncology, Oncology Patients, Phase 1, Clinical Trial, Tumors, Solid Tumors, Angiogenesis Inhibitors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 780Drug
AMG 780 will be administered by IV infusion every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dose Escalation Receives: Drug: AMG 780 |
| B | Experimental | Dose Expansion Receives: Drug: AMG 780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of AMG 780 in subjects with advanced solid malignancies (including adverse event rate, incidence of dose-limiting toxicities, and determination of maximum tolerated dose)
Measured: 2.5 years
To evaluate the pharmacokinetic (PK) parameters of AMG 780 including, but not limited to Cmax, AUC, and accumulation ratio
Measured: 2.5 years
Secondary outcomes (4)
To evaluate tumor response using RECIST criteria (measured by CT/MRI)
Measured: 2.5 years
To evaluate changes in tumor volume (measured by volumetric CT/MRI)
Measured: 2.5 years
To evaluate changes in tumor vascularity and to estimate the relationship between dose/pharmacokinetics and vascular response (measured by DCE-MRI)
Measured: 2.5 years
To evaluate the incidence of anti-AMG 780 antibody formation
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionApr 2014
Why it stopped: Part A, the dose escalation and primary objective of the study, was completed. Part B, the dose expansion, was not conducted due to a business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT01137552
- Sponsor's protocol ID
- 20070879
- Status last verified
- Feb 2015
- First submitted
- 22 Apr 2010
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Crockett SD, Barry EL, Mott LA, Snover DC, Wallace K, Baron JA. Predictors of Incident Serrated Polyps: Results from a Large Multicenter Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2022 May 4;31(5):1058-1067. doi: 10.1158/1055-9965.EPI-21-1226.
PubMed 35506244
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 780 in Adult Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01137552
- Acronym / sponsor ID
- 20070879
- Conditions
- Advanced Solid Tumors
- Keywords
- First-In-Human, Dose Escalation, Dose Expansion, Advance Solid Tumors, Anti-Angiopoietin, Advance Malignancy, Cancer, Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part A, the dose escalation and primary objective of the study, was completed. Part B, the dose expansion, was not conducted due to a business decision.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AMG 780Dose Escalation |
| B | Experimental | Drug: AMG 780Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ≥ 18 years old
- Must have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy
- Measurable disease by RECIST criteria
- Must be able to undergo MRI evaluation
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (19 listed)
- Presence of untreated or symptomatic primary central nervous system tumors or metastases
- Presence of leukemia or myelodysplastic syndrome
- Subjects with head and neck cancer
- Previous hematopoietic stem cell transplant (allogeneic)
- Unresolved hematological toxicities > grade 1 with the exception of grade 2 lymphopenia and non-hematological toxicities > grade 1, excluding alopecia and grade 2 neuropathy, from prior anti-cancer therapy
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 |
|---|---|---|
| AMG 780AMG 780 will be administered by IV infusion every 2 weeks | Drug | A, B |
Primary outcome
To assess the safety and tolerability of AMG 780 in subjects with advanced solid malignancies (including adverse event rate, incidence of dose-limiting toxicities, and determination of maximum tolerated dose)
Time frame: 2.5 years
To evaluate the pharmacokinetic (PK) parameters of AMG 780 including, but not limited to Cmax, AUC, and accumulation ratio
Time frame: 2.5 years
4 secondary outcomes
To evaluate tumor response using RECIST criteria (measured by CT/MRI)
Time frame: 2.5 years
To evaluate changes in tumor volume (measured by volumetric CT/MRI)
Time frame: 2.5 years
To evaluate changes in tumor vascularity and to estimate the relationship between dose/pharmacokinetics and vascular response (measured by DCE-MRI)
Time frame: 2.5 years
To evaluate the incidence of anti-AMG 780 antibody formation
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Part A, the dose escalation and primary objective of the study, was completed. Part B, the dose expansion, was not conducted due to a business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Derived from this study: PubMed 35506244Crockett SD, Barry EL, Mott LA, Snover DC, Wallace K, Baron JA. Predictors of Incident Serrated Polyps: Results from a Large Multicenter Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2022 May 4;31(5):1058-1067. doi: 10.1158/1055-9965.EPI-21-1226.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 780 in people with Advanced Solid Tumors, run by Amgen at 3 sites in United States.
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Part A, the dose escalation and primary objective of the study, was completed. Part B, the dose expansion, was not conducted due to a business decision.). Results are not available in the source record.
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?
To assess the safety and tolerability of AMG 780 in subjects with advanced solid malignancies (including adverse event rate, incidence of dose-limiting toxicities, and determination of maximum tolerated dose) (time frame: 2.5 years). 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?
On the ClinicalTrials.gov record for NCT01137552, which also lists 1 linked publication.
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 4 Mar 2015.