Treatment for Metastatic or Locally Advanced Cervical Cancer Clinical Trial
Official title:
Phase II, Open Label, Non-randomized, Trial of BKM120 as Palliative Treatment for Metastatic or Locally Advanced Cervical Cancer After Failure to Platinum Based Regimen
This is a single arm open label phase II trial to evaluate the oral daily use of BKM 120 in
patients with recurrent unresectable or metastatic cervical cancer after palliative
cisplatin based regimen failure.
A complete treatment cycle is defined as a 28 days period.
Inclusion and exclusion criteria should be assessed in the pretreatment visit and the
informed consent must be taken before treatment assignment. The diagnosis and extent of
disease, the medical history, and the current medical condition should be recorded by the
investigator in a pretreatment visit. Adverse events will be recorded including type,
severity, graded by CTCAE V 3.0, seriousness and potential relation to the investigational
drug.
The efficacy assessment will be done by MRI and recorded in the patients' clinical chart.
Tumor dimension assessments will be performed at baseline through abdominal/pelvic magnetic
resonance imaging, to be repeated in 3 months intervals and evaluated according RECIST
criteria. The first cohort, composed by the 06 first patients, will undergo a separate
positron-emission tomography (PET-CT) evaluation at baseline and 90 days apart.
Laboratory tests (hematology, blood chemistry), ECG and physical examination will be done on
every visit.
Drug pharmacokinetics will not be assessed in this study. For the screening Baseline
periods, see chart attached The treatment will be continued until progressive disease or
intolerable toxicity
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