Phase II, Open Label, Non-randomized, Trial of BKM120 for Metastatic or Locally Advanced Cervical Cancer
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.
Treatment for Metastatic or Locally Advanced Cervical Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Toxicity profile by recording the frequency and severity of adverse events associated to the use of daily oral BKM 120 as assessed by NCI CTCAE v. 3.0 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Clinical benefit [complete response (CR), partial response (PR) rate and stable disease] according to RECIST criteria. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613677
|Novartis Investigative Site|
|Rio de Janiero, RJ, Brazil, 20231-050|
|Study Director:||Novartis Biociências SA - Brazil||Novartis|