A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors

Status Completed

Clinical Trial 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

Clinical Trial Description

This is an open-label study of XMT-1001 administered intravenously over 4 hours every 21 days (1 Cycle). Blood sampling for PK analyses will be performed immediately prior to dosing, and 9 times after dosing. Patients will be assessed for toxicities known to occur with other drugs of this class, such as bone marrow suppression, elevated liver function enzymes, hemorrhagic cystitis, and diarrhea. Tumor imaging will be performed every 2 cycles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00455052
Study type	Interventional
Source	Mersana Therapeutics
Contact
Status	Completed
Phase	Phase 1
Start date	March 2011
Completion date	December 2011

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