A Phase 1/2 interventional study of Fenretinide/LXS + Ketoconazole in Ovarian Cancer, Cancer of Ovary and Cancer of the Ovary, sponsored by South Plains Oncology Consortium. Terminated at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by South Plains Oncology Consortium · Phase 1/2, Interventional, and Treatment
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.
In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →South Plains Oncology Consortium is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Fenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Also known as: 4-HPR, N-(4-hydroxyphenyl)retinamide, Nizoral, Feoris
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.
Time frame: 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.
Time frame: From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
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.
Time frame: 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.
Time frame: 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 -
Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma
Time frame: up to 48 months after the last subject enrolled
Plan to share: Undecided
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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South Plains Oncology Consortium