Clinical trial · Interventional
Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer
NCT04457089CI-TRIAL-00102367completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-sensitive Ovarian Cancer | Platinum-Sensitive Ovarian Carcinoma | ALIAS | 0.90 |
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simvastatin 40mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simvastatin
- interventionNames
- Drug: Simvastatin 40mg
Primary outcomes (1)
- measure
- Completion of the simvastatin intervention with at least 85% compliance
- timeFrame
- From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)
- description
- Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.
Secondary outcomes (2)
- measure
- Response by CA125
- timeFrame
- From baseline until 12 months
- description
- Change in serum level of CA125
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum treatment. * No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin. Exclusion Criteria: * Prior or current use of any statin medication * Current systemic use of medications known to interact with statins * Current use of any other investigational agents * Liver disease, active cirrhosis * Uncontrolled intercurrent illness * History of chronic myopathy * Prior cancer other than ovarian cancer or non-melanomatous skin cancers * Known active infection with HIV * Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day) * Prior exposure to doxorubicin or liposomal doxorubicin * Hemoglobin A1C \>8.0%
References
Publications (0)
Data not yet available
No reference posted for this study.