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

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

Conditions

• Small Cell Lung Cancer
• Non-small Cell Lung Cancer

Interventions

DRUG

XMT-1001

XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD.

Sponsors & Collaborators

• Mersana Therapeutics

  lead INDUSTRY

Principal Investigators

• Edward Sausville, MD · University of Maryland Greenebaum Cancer Center

• Glen J Weiss, MD · TGen Clinical Research Services at Scottsdale Healthcare

• Lawrence Garbo, MD · New York Oncology Hematology

• Allen Lee Cohn, MD · Rocky Mountain Cancer Centers

• Paul R. Conkling, MD · Virginia Oncology Associates

• William J Edenfield, MD · Institute for Translational Oncology Research

• Donald A. Richards, MD · Texas Oncology - Tyler

• John R. Caton, MD · Willamette Valley Cancer Institute and Research Center

• David A. Smith, MD · Northwest Cancer Specialists - Vancouver Cancer Center

• Hillary H. Wu, MD · Central Indiana Cancer Centers

• Fadi Braiteh, MD · Comprehensive Cancer Centers of Nevada

• Stephen Anthony, MD · Evergreen Hematology & Oncology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• United States

Study Locations