EUCTR2012-000675-16-NL
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
ConditionsAdult 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adult patient in advanced pancreatic neuroendocrine tumors
- 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 100
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •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, Cytotoxic chemotherapy, targeted therapy, immunotherapy, radiotherapy, or major
- •surgery within 4 weeks prior to enrolment in the study, Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic 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
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