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| Sponsor: | Mersana Therapeutics |
|---|---|
| Information provided by: | Mersana Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01011972 |
Purpose
XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects may result from blocking the growth of new blood vessels that help the tumors survive.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: XMT-1107 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of the Safety and Pharmacokinetics of XMT-1107 Administered as an Intravenous Infusion Once Every Three Weeks to Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: XMT-1107, intravenous infusion |
Drug: XMT-1107
XMT-1107 is administered IV once every 21 days.
|
This is an open-label, ascending-dose study of XMT-1107 administered intravenously over 90 minutes every 21 days (1 cycle). Blood sampling for PK analyses will be performed immediately prior to dosing and after dosing. Adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 4.0 (CTCAE v4.0)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have the following laboratory values:
Exclusion Criteria:
Patients with proteinuria at screening as demonstrated by either:
Contacts and Locations| United States, Maryland | |
| University of MD Greenbaum Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Lorena Gapasin, RN, BSN, CCRP 410-328-2341 lgapasin@umm.edu | |
| Principal Investigator: Edward Sausville, MD | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute (DFCI) | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Andrew Wolanski, NP 617-632-6623 andrew_wolanski@dfci.harvard.edu | |
| Principal Investigator: Geoffrey I. Shapiro, M.D., Ph.D. | |
| Beth Israel Deaconess Medical Center (BIDMC) | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Janine Morrissey 617-632-9285 jmorriss@bidmc.harvard.edu | |
| Sub-Investigator: Daniel C Cho, M.D. | |
| United States, Tennessee | |
| Sarah Cannon Research Institute (SCRI) | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Research Nurse 615-339-4214 | |
| Principal Investigator: Johanna Bendell, MD | |
More Information
| Responsible Party: | Burkhard Blank, MD, Mersana Medical Monitor, Mersana Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01011972 History of Changes |
| Other Study ID Numbers: | MER-1107-001 |
| Study First Received: | November 10, 2009 |
| Last Updated: | September 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Dose escalation XMT-1107 1107 Tumor Phase 1 Fumagillol |
PHF Fleximer cancer maximum tolerated dose MTD |
|
Neoplasms |