Phase 2 Completed N=73 Treatment

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)

Source: ClinicalTrials.gov NCT00688623 ↗

Enrolled (actual)

Serious AEs

65.8%

Results posted

Jan 2019

Primary outcomePrimary: 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

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.