A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
This trial is active, not recruiting.
|Start date||January 2012|
|End date||May 2012|
|Trial size||24 participants|
|Trial identifier||NCT01224730, Protocol 147|
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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
Perifosine 100 mg orally daily under Fed and Fasted conditions
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
time frame: 24 days
To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies
time frame: Up to 6 months
Male or female participants at least 18 years old.
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
|Official title||A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies|
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