Phase 2
N=73
RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe
Advanced and Metastatic Silent Neuro-Endocrine Tumors · Carcinoma · Neuroendocrine · Non Functioning Neuroendocrine Tumors (NETs) · Non Syndromic Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00688623 ↗Enrolled (actual)
73
Serious AEs
65.8%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP) — 0.0; 0.0; 56.7; 43.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP) |
0.0; 0.0; 56.7; 43.3; 0.0 | — |
| PRIMARY Percentage of Participants With Objective Response Rate at 12 Months - Per Protocol Set (PP) |
0.0 | — |
| PRIMARY Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set |
0.0; 0.0; 74.0; 16.4; 9.6 | — |
| PRIMARY Percentage of Participants With Objective Response Rate at 12 Months ITT Set |
0.0 | — |
| SECONDARY Percentage of Participants With Disease Control Rate (DCR) at 12 Months for Per Protocol (PP) and ITT Sets |
56.7; 50.7 | — |
| SECONDARY Percentage of Participants' Biochemical Response Rate Based on the Tumor Marker Chromogranin A (CgA) |
— | — |
| SECONDARY Duration of Progression Free Survival (PFS) for Per Protocol (PP) and ITT Sets |
185; 190 | — |
| SECONDARY Overall Survival (OS) for Per Protocol (PP) and ITT Sets |
451.8; 437.1 | — |
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.
Eligibility Criteria
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
- Adequate renal function
- Adequate lipid profile
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
- Patients who entered peptide receptor radionuclide therapy (PRRT) within 3 months prior to study entry
- Patients who received CT, biotherapy or radiotherapy within 4 weeks prior to study entry
- Patients who have previously received systemic (mammalian target of rapamycin) mTOR inhibitors
- Patients with a known hypersensitivity to everolimus or other rapamycins or to its excipients
- Patients with uncontrolled central nervous system (CNS) metastases
- Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent
- Patients with a known history of HIV seropositivity
- Patients with autoimmune hepatitis
- Patients with an active, bleeding diathesis
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
- Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start
- Patients unwilling to or unable to comply with the protocol
Data sourced from ClinicalTrials.gov (NCT00688623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.