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Spots Global Cancer Trial Database for Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

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Trial Identification

Brief Title: Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

Official Title: An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer

Study ID: NCT00442598

Conditions

Ovarian Cancer

Interventions

Glufosfamide

Study Description

Brief Summary: Primary Objectives: * To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer * To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing Secondary objectives: * To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival * To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment Exploratory objective: * To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Detailed Description: Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen. In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Premiere Oncology of Arizona, Scottsdale, Arizona, United States

Arizona Cancer Center, Tucson, Arizona, United States

California Cancer Center, Greenbrae, California, United States

UCI Chao Family Comprehensive Cancer Center, Orange, California, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

Louisville Oncology Clinical Research Program, Louisville, Kentucky, United States

New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States

Gabrail Cancer Center, Canton, Ohio, United States

Gynecologic Oncology Research & Development, LLC, Greenville, South Carolina, United States

Harrington Cancer Center, Amarillo, Texas, United States

Contact Details

Name: David Alberts, MD

Affiliation: University of Arizona

Role: PRINCIPAL_INVESTIGATOR

Name: Michael Gordon, MD

Affiliation: Premiere Oncology of Arizona

Role: PRINCIPAL_INVESTIGATOR

Name: Daniela Matei, MD

Affiliation: Indiana University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Peter D Eisenberg, MD

Affiliation: California Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Name: Larry Puls, MD

Affiliation: Gynecologic Oncology Research & Development, LLC

Role: PRINCIPAL_INVESTIGATOR

Name: Krishnansu Tewari, MD

Affiliation: UCI Chao Family Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Name: Nashat Gabrail, MD

Affiliation: Gabrail Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Name: Jeffrey Goldberg, MD

Affiliation: Louisville Oncology Clinical Research Program

Role: PRINCIPAL_INVESTIGATOR

Name: Claire Verschraegen, M.D.

Affiliation: New Mexico Cancer Care Alliance

Role: PRINCIPAL_INVESTIGATOR

Name: William Robinson, MD

Affiliation: Harrington Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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