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An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

2014-08-27 03:53:12 | BioPortfolio

Summary

This study tests the safety and effectiveness of a YONDELIS® (trabectedin) and DOXIL/CAELYX (herein referred to as DOXIL) combination to DOXIL alone.

Description

This is a multicenter, open-label, randomized, Phase 3 study comparing the combination of Doxil, 30mg/m2, administered as a 90-minute infusion followed by trabectedin, 1.1 mg/m2 3-hour infusion, every 3 weeks with DOXIL, 50 mg/m2 as a 90-minute infusion every 4 weeks, in previously treated patients with advanced ovarian cancer for whom first-line platinum-based chemotherapy regimen has failed. The purpose of this research study is to determine if the combination of trabectedin and DOXIL is better at improving progression free survival over DOXIL alone in patients with relapsed advanced ovarian cancer. Additional comparisons between the two treatment groups include: overall survival, measurement of disease progression, response rate, (how much your tumor shrinks in response to the drug) safety, pharmacokinetics (measuring the amount of drug in your body), quality of life, and optional measurement of circulating tumor cells if present. Patients may receive either a combination of trabectedin and DOXIL (Group A) or DOXIL alone (Group B). If you are in Group A you will receive dexamethasone followed by Trabectedin 1.1 mg/m² as a 3 hour infusion + DOXIL 30 mg/m² every 3 weeks as long as you are responding to treatment. If you are in Group B you will receive DOXIL 50 mg/m2 every 4 weeks as long as you are responding to treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ovarian Cancer

Intervention

DOXIL, trabectedin + DOXIL

Status

Active, not recruiting

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:12-0400

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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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