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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: Completed Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Mersana Therapeutics.

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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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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

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

FieldValue
Enrollment Target 30 participants
Start Date 2011-03
Est. Completion 2011-12
Phase Phase 1
Mersana Therapeutics

11 total trials

What the finished NCT00455052 record still lists

NCT00455052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower).

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 lists 12 locations in 11 states (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.

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00455052's enrollment target sits among peer trials

30 387th of 454 higher than 58 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00455052, the US trial registry maintained by the National Library of Medicine. NCT00455052 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.