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AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Plain-language guide to NCT00147225: phase 1, phase 2 non-randomized trial of Romiplostim, 55 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00147225
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2005-08
- Completion (planned or actual)
- 2013-03
- Participants
- 55 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Solid Tumors; Advanced Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Romiplostim.
To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2.
It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
More on the Plan
Platelets are cells that help make the blood clot.
Researchers want to find out if AMG 531 can lower the risk and severity of this side effect.
AMG 531 is a protein that stimulates platelet production.
In Cycle 1, all patients will receive chemotherapy by itself.
Who Took Part
The registry lists 55 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age \>/= 18 years. Karnofsky Performance Status \>/= 80. Signed informed consent form.
The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: patients with rapidly progressive disease (such as patients with rapidly accumulating ascites or pleural effusion); patients with hematologic malignancies; pregnant or lactating women.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-08 with completion listed for 2013-03.
It ran at 1 site in United States.
Its stated primary purpose is prevention.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, non-randomized trial of Romiplostim in 55 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Romiplostim compound page, all human trials.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.