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NCT00531284 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma
A Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 184
- Enrollment target
- 7
- Study locations
NCT00531284: Completed Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma, sponsored by Amgen.
NCT00531284 is a Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma that has completed, run by Amgen. The registered enrollment target is 184 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (72% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00531284, a Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 184 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary objectives of this Phase 1b/2 study were as follows: * Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma. * Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.
Primary Outcome
Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding. The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) wa
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Carfilzomib
Study Locations (7)
Arizona
- Pinnacle Oncology - Scottsdale
California
- Tower Cancer Research Foundation - Beverly Hills
Illinois
- Northwestern University - Chicago
Maryland
- University of Maryland Greenebaum Cancer Center - Baltimore
New Jersey
- Hackensack University Medical Center - Hackensack
Tennessee
- The Sarah Cannon Research Institute - Nashville
Texas
- South Texas Accelerated Research Therapeutics (START) - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2007-09 |
| Est. Completion | 2017-05-22 |
| Phase | Phase 1 |
What the finished NCT00531284 record still lists
NCT00531284 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (72% lower).
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00531284 lists 7 locations in 7 states (Arizona, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT00531284 about?
NCT00531284 is a clinical study titled "Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma". The primary objectives of this Phase 1b/2 study were as follows: * Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma. ...
What is the current status of trial NCT00531284?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 184 participants. The study started on 2007-09. Estimated completion is 2017-05-22.
What conditions does trial NCT00531284 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Multiple Myeloma, Ovarian Cancer, Lymphoma, Solid Tumors.
What interventions are being tested in trial NCT00531284?
The interventions under investigation include: Dexamethasone (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT00531284?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00531284 being conducted?
This trial has 7 study locations across Arizona, California, Illinois, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00531284's enrollment target sits among peer trials
184 172nd of 454 higher than 282 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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