drug combination not providing any efficacy. Will use this data in opening new trial
Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Sponsor study identifier
interventional
12
1 country
3
Study Start
February 2012
Actual (reported)Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Actual (reported)February 3, 2012
Actual (reported)February 17, 2012
Actual (reported)June 2017
Actual (reported)June 2017
Actual (reported)Phase 2: Progression Free Survival
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
Phase 2: Overall Survival
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
One course is defined as 7 days of Fenretinide/LXS + Ketoconazole followed by 14 days of rest. A course is repeated every 21 days if no evidence of disease progression for six courses.
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Fenretinide/LXS + Ketoconazole
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79416, United States
Jayanthi Lea, MD
University of Texas Southwestern Medical Center
Barry J Maurer, MD, PhD
Texas Tech University Health Sciences Center
12 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2012
First Posted
February 17, 2012
Study Start
February 2012
Actual (reported)Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
From time of first dose to the last (average 6 months)
Phase 2: Event Free Survival
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
From enrollment up to the first date of progressive disease or death from any cause (up to 48 months after last patient entered on treatment)
Pharmacokinetics -
up to 48 months after the last subject enrolled
Contact the study team to confirm eligibility.
Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)Last Updated
August 27, 2020
Record last verified: 2020-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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