Trials / Terminated
TerminatedNCT01535157
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- South Plains Oncology Consortium · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fenretinide/LXS + Ketoconazole | Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2012-02-17
- Last updated
- 2020-08-27
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01535157. Inclusion in this directory is not an endorsement.