Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2012-07-31
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
NCT01331941
Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
NCT00102830
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
NCT06333951
A Study of AMG 193 in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
NCT05094336
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
NCT04362748
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AMG 386 15mg/kg and paclitaxel 80mg/m2
AMG 386
Weekly 15 mg/kg of AMG 386 in combination with three weeks on/ one week off 80mg/m2 of paclitaxel. Continued therapy with AMG 386 with or without paclitaxel until progression, unacceptable toxicity develops, or study withdrawal.
Paclitaxel
Three weeks on/ one week off 80mg/m2 of paclitaxel in combination with weekly 15 mg/kg of AMG 386 . Continued therapy with AMG 386 until progression, unacceptable toxicity develops, or study withdrawal. A cycle consists of 3 weeks on / 1 week off of paclitaxel.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AMG 386
Weekly 15 mg/kg of AMG 386 in combination with three weeks on/ one week off 80mg/m2 of paclitaxel. Continued therapy with AMG 386 with or without paclitaxel until progression, unacceptable toxicity develops, or study withdrawal.
Paclitaxel
Three weeks on/ one week off 80mg/m2 of paclitaxel in combination with weekly 15 mg/kg of AMG 386 . Continued therapy with AMG 386 until progression, unacceptable toxicity develops, or study withdrawal. A cycle consists of 3 weeks on / 1 week off of paclitaxel.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Normal or clinically acceptable ECG (12 lead reporting PR, QRS, QTc)
Exclusion Criteria
* Known history of primary central nervous system (CNS) tumors or CNS metastases
* Myocardial infarction within 1 year before study day 1, 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 day 1
* A baseline ECG QTc interval \> 450 msec
* Active grade 2 or greater peripheral vascular disease
* History of pulmonary hemorrhage or gross hemoptysis within 6 months before study day 1
* Non-healing wound, ulcer (including gastrointestinal) or fracture
* Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection
* Major surgery within 1 month before study day 1
* Concurrent antitumor treatment within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1
* Unable to tolerate IV administration or repeated blood withdrawal
* Hypersensitivity to paclitaxel or drugs using the vehicle cremophor
* Known sensitivity to mammalian-derived products, bacterially-produced proteins, or any of the products to be administered during dosing
* Chronic neuropathy grade ≥ 1
* Concurrent or prior treatment with 2C8 and 3A4 substrates
* Enrolled in or has not yet completed at least 30 days (prior to study day 1) since ending other investigational device or drug, or currently receiving other investigational treatment.
* Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 6 months after the last dose of AMG 386
* Women who are lactating/breastfeeding
* Women with a positive pregnancy test
* Women planning to become pregnant during the duration of the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20101151
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.