A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumor
This study is currently recruiting participants.
Verified July 2012 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01137552
First received: April 22, 2010
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: AMG 780 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate the pharmacokinetic (PK) parameters of AMG 780 including, but not limited to Cmax, AUC, and accumulation ratio [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate tumor response using RECIST criteria (measured by CT/MRI) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- To evaluate changes in tumor volume (measured by volumetric CT/MRI) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To evaluate the incidence of anti-AMG 780 antibody formation [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 62 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Dose Escalation
|
Drug: AMG 780
AMG 780 will be administered by IV infusion every 2 weeks
|
|
Experimental: B
Dose Expansion
|
Drug: AMG 780
AMG 780 will be administered by IV infusion every 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137552
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Locations
| United States, California | |
| Research Site | Recruiting |
| Los Angeles, California, United States, 90048 | |
| United States, North Carolina | |
| Research Site | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Research Site | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01137552 History of Changes |
| Other Study ID Numbers: | 20070879 |
| Study First Received: | April 22, 2010 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013