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NCT00147225 · ClinicalTrials.gov registry record · Phase 1
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT00147225: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00147225 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00147225, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1\. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy
Interventions
- DRUG Carboplatin
- DRUG Ifosfamide
- DRUG Adriamycin
- DRUG AMG 531
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2005-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00147225
The ClinicalTrials.gov registry entry for NCT00147225 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00147225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00147225 about?
NCT00147225 is a clinical study titled "AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin". The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Pr...
What is the current status of trial NCT00147225?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2005-08. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00147225?
The interventions under investigation include: Carboplatin (DRUG), Ifosfamide (DRUG), Adriamycin (DRUG), AMG 531 (DRUG).
Who is sponsoring clinical trial NCT00147225?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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