A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
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Official title
A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00455052
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2011 (Actual)
- Primary completion
- Dec 2011 (Actual)
- Completion
- Dec 2011 (Actual)
- Last update posted
- Jan 31, 2018
2011
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Central Indiana Cancer Centers | Indianapolis | Indiana | 46219 | — |
| University of Maryland, Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| New York Oncology Hematology | New York | New York | 12208 | — |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | — |
| Institute of Translational Oncology Research | Greenville | South Carolina | 29605 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Evergreen Hematology & Oncology | Spokane | Washington | 99218 | — |
| Vancouver Cancer Center | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00455052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2018 · Synced Nov 11, 2026
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