EUCTR2012-000675-16-DE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria: Unresectable or metastatic, histologically confirmed low or intermediate grade pancreatic neuroendocrine
- •tumor with radiological evidence of disease progression since last treatment. Refractory disease to treatment with mTOR
- •inhibitor, Measurable disease per RECIST Version 1\.1 using Computed Tomography (CT) or Magnetic Resonance Imaging
- •(MRI), Prior or concurrent therapy with SSA is permitted;a stable dose at least 2 months prior to study start and must
- •continue on the stable dose while receiving study treatment; Other protocol defined inclusion/exclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Previous treatment with any PI3K or AKT inhibitor\- Discontinuation prior mTOR inhibitor therapy due to toxicity\- Poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma\- Radiotherapy, or major surgery within 4 weeks prior to study treatment start
- •\- Hepatic artery embolization or cryoablation/ radiofrequency ablation ofhepatic metastasis within 2 months of enrollment\- More than 3 prior systemic treatment regimens\- Other protocol defined inclusion/exclusion criteria may apply
Outcomes
Primary Outcomes
Not specified
Similar Trials
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 therapyNETpancreas neuroendocrine tumor10014713NL-OMON37043ovartis5
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)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