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Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer

2014-08-27 03:53:52 | BioPortfolio

Summary

The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24 hour period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ovarian Cancer

Intervention

Ispinesib

Location

GSK Investigational Site
Birmingham
Alabama
United States
35205

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:52-0400

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Medical and Biotech [MESH] Definitions

Autosomal dominant HEREDITARY CANCER SYNDROME in which a mutation most often in either BRCA1 or BRCA2 is associated with a significantly increased risk for breast and ovarian cancers.

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

A homolog of p53 TUMOR SUPPRESSOR PROTEIN that encodes full-length trans-activating and N-terminally-truncated (DeltaN) isoforms. Detection of splice variants and isoforms in the nervous system (human TELENCEPHALON, CHOROID PLEXUS; CEREBROSPINAL FLUID), embryonic tissue, human BREAST CANCER; OVARIAN CANCER, suggest roles in cellular differentiation.

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