RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe (NCT00688623) | Clinical Trial Compass
CompletedPhase 2
RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe
France, Germany73 participantsStarted 2009-06-24
Plain-language summary
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 18 years old
✓. Patients with advanced (unresectable or metastatic) biopsy proven non-syndromic neuro-endocrine carcinoma, low or intermediate grade
✓. Radiological documentation of disease progression within 12 months prior to study entry. If patients received anti-tumor therapy during the past 12 months, they must have radiological documentation of progressive disease (PD) while on or after receiving the therapy
✓. Patients may have received previous treatments (chemotherapy, biotherapy, peptide-receptor radionuclide therapy); an overall maximum of 3 systemic treatment is allowed
✓. Patients with at least one measurable lesion
✓. Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
✓. Adequate bone marrow function
✓. Adequate liver function
Exclusion criteria
✕. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
✕. Patients with carcinoid with hormone related symptoms (diarrhea ≥ 4 stools per day and/or flushes)
✕. Patients with Islet cell carcinomas or pancreatic NET
✕. Patients who received prior therapy with Vascular Endothelial Growth Factor (VEGF) pathway inhibitor within 4 weeks prior to study entry
What they're measuring
1
Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)
Timeframe: baseline up to approximately 12 months
2
Percentage of Participants With Objective Response Rate at 12 Months - Per Protocol Set (PP)
Timeframe: baseline up to approximately 12 months
3
Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set
Timeframe: baseline up to approximately 12 months
4
Percentage of Participants With Objective Response Rate at 12 Months ITT Set