RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

40 sites in 8 countries.

About this study

Official title: A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-endocrine Tumors

Conditions

Advanced and Metastatic Silent Neuro-Endocrine Tumors, Carcinoma, Neuroendocrine, Non Functioning Neuroendocrine Tumors (NETs), Non Syndromic Neuroendocrine Tumors, Carcinoids

Being tested

Everolimus

Keywords

Neuroendocrine tumors, non functioning neuroendocrine tumors, Non syndromic neuroendocrine tumors, carcinoids, non-functioning carcinoids, adults, everolimus, NET, RAMSETE, CRAD001, non-functioning neuroendocrine tumors carcinoids

Medical subject headings

Carcinoma, Carcinoid Tumor, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• EverolimusDrug

  Everolimus 5 mg tablets were supplied in blister packs

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)

   Overall response rate (ORR) was based on RECIST central assessment and defined as the percentage of patients with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR). The BOR was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments obtained within 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. CR required disappearance of all target and non-target lesions.

   Measured: baseline up to approximately 12 months

2. Percentage of Participants With Objective Response Rate at 12 Months - Per Protocol Set (PP)

   Overall Response Rate (ORR) was calculated for total PP population based on central review as confirmatory, primary analysis as well as for ITT population as sensitivity analysis. It was presented with relative frequencies and the exact 2-sided 80% confidence limit (CI) computed using the Clopper-Pearson method). If the lower limit of the CI did not include p0=5%, the hypothesis that p ≤ 5% was rejected. The primary analysis was based on the PP Set

   Measured: 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

   The best overall response (BOR) was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed not less than 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

   CR required disappearance of all target and non-target lesions.

   Measured: baseline up to approximately 12 months

4. Percentage of Participants With Objective Response Rate at 12 Months ITT Set

   Overall Response Rate (ORR) was presented for ITT population as sensitivity analysis. It was presented with relative frequencies and the exact 2-sided 80% confidence limit (CL; computed using the Clopper-Pearson method). If the lower limit of the CI did not include p0=5%, the hypothesis that p ≤ 5% was rejected.

   Measured: baseline up to approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Jun 2008 (estimated)
2. Study start24 Jun 2009
3. Primary completion7 Nov 2016
4. Study completion7 Nov 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Advanced and Metastatic Silent Neuro-Endocrine TumorsStudies of the same condition, open and under way.
• More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.