NL-OMON37043
Completed
Phase 2
A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy - phase 2 study to the efficacy of BEZ235 in patients with pancreas NET
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- NET
- Sponsor
- ovartis
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient must have advanced, histologically confirmed low or intermediate grade pancreatic pNET according to the WHO 2010 classification and show radiological evidence of disease progression since last treatment.
- •NOTE: Tissue (archival or fresh) must be provided if available in order to identify molecular profiles relevant to PI3K pathway signaling.
- •2\. Patients\* disease is refractory to treatment with mTOR inhibitor. Patients must not have taken another treatment between mTOR inhibitor and BEZ235\.
- •NOTE: Refractory is defined as progression while on treatment or within 3 months of treatment discontinuation.
- •3\. Measurable disease per RECIST Version 1\.1 using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).
- •4\. Prior or concurrent therapy with SSA is permitted; however, for concurrent therapy with SSA while on study, patients must be on a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment.
- •5\. Adequate bone marrow function or organ function as shown by:
- •\* Absolute Neutrophil Count (ANC) \* 1\.5 x 109/L,
- •\* Platelets \* 100 x 109/L
- •\* Hemoglobin \> 9 g/dL
Exclusion Criteria
- •1\. Patient has received previous treatment with any PI3K inhibitor or AKT inhibitor for the treatment of pNET.
- •2\. Patient has discontinued prior mTOR inhibitor therapy due to toxicity
- •3\. Patient has poorly differentiated neuroendocrine carcinoma, high\-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma.
- •4\. Patient has received cytotoxic chemotherapy, targeted therapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to enrolment in the study.
- •5\. Patient has been treated with hepatic artery embolization within the last 6 months or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment.
- •6\. Patients with more than 3 prior systemic treatment regimens.
- •7\. Patient is being treated at start of study treatment with any of the following drugs:
- •\* Drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A4
- •\* Drugs with a known risk to induce Torsades de Pointes
- •\* Warfarin and coumarin analogues
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)Adult patient in advanced pancreatic neuroendocrine tumorsMedDRA version: 14.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-000675-16-ITOVARTIS FARMA150
Active, not recruiting
Not Applicable
Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)Adult patient in advanced pancreatic neuroendocrine tumorsMedDRA version: 14.1Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-000675-16-NLovartis Pharma Services AG150
Active, not recruiting
Phase 1
Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)EUCTR2012-000675-16-GBovartis Pharma Services AG31
Active, not recruiting
Not Applicable
Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)EUCTR2012-000675-16-DEovartis Pharma Services AG150
Active, not recruiting
Not Applicable
Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)Adult patient in advanced pancreatic neuroendocrine tumorsMedDRA version: 14.1Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-000675-16-ATovartis Pharma Services AG150