Safety Study of PLX108-01 in Patients With Solid Tumors
Summary
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. These tumors include, but are not limited to, acute myelogenous leukemia (Flt3), gastrointestinal stromal tumor and neurofibromatosis-1 (Kit), and glioma, breast cancer, prostate cancer, multiple myeloma, and osteosarcoma (Fms/CSF-1). The secondary objective is to measure the pharmacodynamic activity of PLX3397 via plasma and urine biomarkers of Fms activity.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Solid Tumors
Intervention
PLX3397
Location
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale
Arizona
United States
85258
Status
Recruiting
Source
Plexxikon
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01004861
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lomustine
An alkylating agent of value against both hematologic malignancies and solid tumors.
Brenner Tumor
A smooth, solid or cystic fibroepithelial (FIBROEPITHELIAL NEOPLASMS) tumor, usually found in the OVARIES but can also be found in the adnexal region and the KIDNEYS. It consists of a fibrous stroma with nests of epithelial cells that sometimes resemble the transitional cells lining the urinary bladder. Brenner tumors generally are benign and asymptomatic. Malignant Brenner tumors have been reported.
Bleomycin
A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.
Mitomycins
A group of methylazirinopyrroloindolediones obtained from certain Streptomyces strains. They are very toxic antibiotics used as ANTINEOPLASTIC AGENTS in some solid tumors. PORFIROMYCIN and MITOMYCIN are the most useful members of the group.
Chromomycins
A complex of several closely related glycosidic antibiotics from Streptomyces griseus. The major component, CHROMOMYCIN A3, is used as a fluorescent stain of DNA where it attaches and inhibits RNA synthesis. It is also used as an antineoplastic agent, especially for solid tumors.
Clinical Trials
A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors
The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability,...
Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
The purpose of this study is to test the safety and effectiveness of 2 drugs, perifosine in combination with temsirolimus in children with solid tumors. Neither drug is currently part of t...
The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.
A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors
This is an open label, single arm, dose escalation study of ARQ 197 in patients with advanced solid tumors.
This study is a Phase I study using vinblastine and sirolimus in patients with relapsed solid tumors including selected brain tumors and lymphoma. The investigators hypothesis is that the...
PubMed Articles
Neurofibromatosis type 1 (NF1) is a common genetic disease that predisposes 30-50 % of affected individuals to develop plexiform neurofibromas. We found that macrophage infiltration of both mouse and...
Bioimaging and therapeutic agents accumulated in ectopic tumors following intravenous administration of hybrid nanocrystals to tumor-bearing mice. Solid, nanosized paclitaxel crystals physically incor...
Detection of recurrent somatic rearrangements routinely allows monitoring of residual disease burden in leukemias, but is not used for most solid tumors. However, next-generation sequencing now allows...
CT and MR features of struma ovarii.
OBJECTIVE: The purpose of this study is to investigate radiologic findings of struma ovarii, and to correlate both CT and MR findings. MAT...
Incidence of anemia, leukocytosis, and thrombocytosis in patients with solid tumors in China.
Despite the fact that malignancies are associated with hematological abnormalities, some clinical studies have been unable to detect such a relation. The aim of our study was to detect the prevalence...
