Trial · NCT01535157
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
NCT01535157, Phase 1, Phase 2, Terminated, South Plains Oncology Consortium
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer. Trials, record NCT01535157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01535157
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
- NCT number
- NCT01535157
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- South Plains Oncology Consortium
- Conditions
- Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasms, Primary Peritoneal Carcinoma
- Interventions
- Fenretinide/LXS + Ketoconazole
- First posted
- 2012-02-17
- Last updated
- 2020-08-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2: Progression Free Survival | From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment) | 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. |
| Primary | Phase 2: Overall Survival | From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment) | 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. |
| Primary | Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole | From time of first dose to the last (average 6 months) | Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. |
| Primary | Phase 2: Event Free Survival | 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) | 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. |
| Secondary | Pharmacokinetics - | up to 48 months after the last subject enrolled | Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01535157
GET https://conductscience.org/api/trials/v1/NCT01535157/registered