A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Summary
The primary objective of this study is to determine how much XMT-1001 can safely be taken by patients with advanced solid cancerous tumors (the Maximum Tolerated Dose).
The study will also determine:
- The recommended dose of XMT-1001 for the next human study
- The safety and tolerability of XMT-1001
- The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body)
- Evidence of XMT-1001 anti-tumor activity
Description
This is an open-label, ascending-dose cohort (group) study of XMT-1001 administered intravenously over 30 minutes 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
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Advanced Cancer (Solid Tumors)
Intervention
XMT-1001
Location
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale
Arizona
United States
85258
Status
Recruiting
Source
Mersana Therapeutics
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00455052
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Adenocarcinoma, Clear Cell
An adenocarcinoma characterized by the presence of varying combinations of clear and hobnail-shaped tumor cells. There are three predominant patterns described as tubulocystic, solid, and papillary. These tumors, usually located in the female reproductive organs, have been seen more frequently in young women since 1970 as a result of the association with intrauterine exposure to diethylstilbestrol. (From Holland et al., Cancer Medicine, 3d ed)
Krukenberg Tumor
Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)
Testolactone
An antineoplastic agent that is a derivative of progesterone and used to treat advanced breast cancer.
Neuroectodermal Tumors, Primitive
A group of malignant tumors of the nervous system that feature primitive cells with elements of neuronal and/or glial differentiation. Use of this term is limited by some authors to central nervous system tumors and others include neoplasms of similar origin which arise extracranially (i.e., NEUROECTODERMAL TUMORS, PRIMITIVE, PERIPHERAL). This term is also occasionally used as a synonym for MEDULLOBLASTOMA. In general, these tumors arise in the first decade of life and tend to be highly malignant. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, p2059)
Lomustine
An alkylating agent of value against both hematologic malignancies and solid tumors.
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