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COMPLETED Phase 1

Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer

NCT00408226 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 27 participants
Start Date 2006-10
Est. Completion 2012-01
Phase Phase 1

Sponsor

CASI Pharmaceuticals

6 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CASI Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00408226 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Indiana, Iowa, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00408226?

The interventions under investigation include: pemetrexed (DRUG), MKC-1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00408226?

This trial is sponsored by CASI Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial