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NCT00455052 · ClinicalTrials.gov registry record · Phase 1
A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Mersana Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 12
- Study locations
NCT00455052 is a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer that has completed, run by Mersana Therapeutics. The registered enrollment target is 30 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 11 states.
The verdict
NCT00455052, a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, has completed, sponsored by Mersana Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 12
- Study locations
Study Summary
This amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow toxicity was observed as compared to more heavily pre-treated patients in the dose escalation part of the study. Therefore, this amended expansion phase will investigate the safety and anti-tumor effects of a dose of 150 mg CPT eq/m2. The study will also determine: * The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2 * The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer * Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2
Conditions Studied
Interventions
- DRUG XMT-1001
Study Locations (12)
Washington
- Evergreen Hematology & Oncology - Spokane
- Vancouver Cancer Center - Vancouver
Arizona
- TGen Clinical Research Services at Scottsdale Healthcare - Scottsdale
Colorado
- Rocky Mountain Cancer Centers - Denver
Indiana
- Central Indiana Cancer Centers - Indianapolis
Maryland
- University of Maryland, Greenebaum Cancer Center - Baltimore
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
New York
- New York Oncology Hematology - New York
Oregon
- Willamette Valley Cancer Institute and Research Center - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00455052
The ClinicalTrials.gov registry entry for NCT00455052 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 (95% lower). The listed sponsor is Mersana Therapeutics, which has 11 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 1 intervention - of which XMT-1001 is the first listed.
NCT00455052 reports 12 study locations spanning 11 distinct geographic areas - top geographies include Washington, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT00455052 about?
NCT00455052 is a clinical study titled "A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors". This amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The MTD was initially def...
What is the current status of trial NCT00455052?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-03. Estimated completion is 2011-12.
What conditions does trial NCT00455052 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Small-cell Lung Cancer.
What interventions are being tested in trial NCT00455052?
The interventions under investigation include: XMT-1001 (DRUG).
Who is sponsoring clinical trial NCT00455052?
This trial is sponsored by Mersana Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00455052 being conducted?
This trial has 12 study locations across Arizona, Colorado, Indiana, Maryland, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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