A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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