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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00822939 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. ON 01910.Na may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with ON 01910.Na may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ON 01910.Na when given together with gemcitabine in treating patients with advanced or metastatic solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Polo-like kinase 1 inhibitor ON 01910.Na Drug: gemcitabine hydrochloride Genetic: polymerase chain reaction Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy Procedure: fine-needle aspiration |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Dose Escalation Study of Gemcitabine and ON 01910.Na in Patients With Advanced or Metastatic Solid Tumors |
Estimated Enrollment: | 35 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter, dose-escalation study of ON 01910.Na.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and ON 01910.Na IV over 2 hours on days 1, 4, 8, 11, 15, and 18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Some patients undergo blood periodically for pharmacokinetic analysis by HPLC. Tumor tissue samples are collected via fine needle aspiration biopsies and analyzed by real time PCR for cDNA synthesis and quantitation of polo-like kinase 1 inhibitor.
After completion of study therapy, patients are followed at 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid malignancy
Meets either of the following criteria:
PATIENT CHARACTERISTICS:
No evidence of active heart disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiotherapy or chemotherapy and recovered
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 |
Principal Investigator: | Wen Wee Ma, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Wen Wee Ma ) |
Study ID Numbers: | CDR0000632302, RPCI-I-137508, ONCONOVA-04-09 |
Study First Received: | January 14, 2009 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00822939 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Antimetabolites Anti-Infective Agents Radiation-Sensitizing Agents Immunologic Factors |
Gemcitabine Immunosuppressive Agents Antiviral Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine |