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NCT00408226 · ClinicalTrials.gov registry record · Phase 1
Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Advanced Cancer, sponsored by CASI Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 4
- Study locations
NCT00408226 is a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Cancer that has completed, run by CASI Pharmaceuticals. The registered enrollment target is 27 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT00408226, a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Cancer, has completed, sponsored by CASI Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 4
- Study locations
Study Summary
To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS"), of oral MKC-1, administered on this schedule in combination with pemetrexed to patients with non small cell lung cancer (NSCLC).
Conditions Studied
Interventions
- DRUG pemetrexed
- DRUG MKC-1
Study Locations (4)
Indiana
- Indiana University Cancer Center - Indianapolis
Iowa
- University of Iowa - Iowa City
Washington
- Swedish Cancer Institute - Seattle
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-10 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00408226
The ClinicalTrials.gov registry entry for NCT00408226 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The listed sponsor is CASI Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which pemetrexed is the first listed.
NCT00408226 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Indiana, Iowa, Washington.
Frequently Asked Questions
What is clinical trial NCT00408226 about?
NCT00408226 is a clinical study titled "Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer". To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor m...
What is the current status of trial NCT00408226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2006-10. Estimated completion is 2012-01.
What conditions does trial NCT00408226 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Advanced Cancer.
What interventions are being tested in trial NCT00408226?
The interventions under investigation include: pemetrexed (DRUG), MKC-1 (DRUG).
Who is sponsoring clinical trial NCT00408226?
This trial is sponsored by CASI Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00408226 being conducted?
This trial has 4 study locations across Indiana, Iowa, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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