Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors
- Conditions
- NETpancreas neuroendocrine tumor10014713
- Registration Number
- NL-OMON40098
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
1. Advanced (unresectable or metastatic), histologically confirmed well differentiated pancreatic neuroendocrine tumor (pNET)
2. Radiological documentation of progressive disease within the last 12 months prior to randomization.
3. Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT.
4. WHO performance status * 2
5. Patient is * 18 years of age on the day of consenting to the study
6. Patient has adequate bone marrow and organ function shown by:
* ANC * 1.5 x 109/L
* trombocyten * 100 x 109/L
* Hemoglobine * 9.0 g/dL
* INR < 1.3
* ALAT en ASAT * 2.5 x ULN. Patients with known liver metastases who have an AST and ALT * 5 x ULN
* Total serum bilirubin * 1.5 x ULN
* Serum creatinine * 1.5 x ULN
* Fasting plasma glucose (FPG) * 140 mg/dL [7.8 mmol/L]
* HbA1c * 8%
7. Fasting serum cholesterol * 300 mg/dL OR * 7.75 mmol/L AND fasting triglycerides * 2.5 x ULN.
1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
2. Previous treatment with PI3K and/or mTOR pathway inhibitors
3. Patients with more than 2 prior systemic treatment regimens
4. Patient has a known hypersensitivity, intolerance and/or contraindications to any of the study medications
5. Patient is receiving (or is planned to receive) any concurrent anti-neoplastic agents except SSA during the study
6. Patient has a concurrent malignancy or has had a malignancy within the last 3 years before study enrollment (except adequately treated cervical cancer in situ or non-melanoma skin cancer)
7. Patient has a history or active severe and/or uncontrolled cardiac conditions that could affect the participation in the study including any of the following:
8. Patient with inadequately controlled hypertension (i.e., SBP > 180 mmHg or DBP > 100 mmHg)
9. Patient has uncontrolled diabetes mellitus
10. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 (e.g. ulcerative diseases, uncontrolled nausea, vomiting, malabsorption syndrome or small bowel resection)
11. Patient is receiving chronic treatment with systemic high dose steroids or other immuno-suppressive agent at start of study treatment
12. Patient is consuming Seville oranges, grapefruit, grapefruit hybrids, pomelo and exotic citrus fruits (as well as their juices) during the last 7 days prior to start of treatment. Regular orange juice is permitted.
13. Immunocompromised patients including known seropositivity for HIV (testing is not mandatory)
14. Patient with diarrhea * Grade 2
15. Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator*s judgment, contraindicated participation in the clinical study such as:
16. Patient is not able to understand or comply with study instructions and requirements or has a history of non-compliance to medical regimen
17. Pregnant or nursing (lactating) women,
18. Patient is a woman of child-bearing potential, , UNLESS she is using highly effective methods of contraception during dosing and for 12 weeks after study treatment discontinuation.
19. Patient is a fertile male, defined as a male physiologically capable of offspring, UNLESS he uses condoms during treatment and for 12 weeks after stopping study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival based on investigator assessment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Frequency and severity of adverse events; other safety data as considered<br /><br>appropriate<br /><br><br /><br>Objective Response Rate (best overall response)<br /><br><br /><br>Overall survival<br /><br><br /><br>Time to treatment failure</p><br>