Clinical trial · Interventional
A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
NCT01224730CI-TRIAL-00032073completedPhase 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 Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated. Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perifosine 100 mg
- description
- Perifosine 100 mg orally daily under Fed and Fasted conditions
- interventionNames
- Drug: perifosine
Primary outcomes (1)
- measure
- To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters
- timeFrame
- 24 days
- description
- * To assess the Pharmacokinetic profile of perifosine when given to patients under fed and fasted conditions * To evaluate changes in other ECG parameters associated with perifosine treatment (ventricular rate, PR interval, QRS interval, QT interval)
Secondary outcomes (1)
- measure
- To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced malignancies * Patients with adequate organ and marrow function Exclusion Criteria: * Patients previously treated with perifosine * Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) prior to Day 1 of study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.